GOVERNMENT OF INDIA 

MINISTRY OF HEALTH AND FAMILY 
WELFARE 

(Department of Health) 

THE DRUGS AND COSMETICS ACT 
AND RULES 

THE DRUGS AND COSMETICS ACT, 1940 

(23 OF 1940) 

(As amended  up to the 31st  December, 2016) 

and 

THE DRUGS AND COSMETICS RULES, 1945 

(As amended  up to the 31st  December, 2016) 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LIST OF ABBREVIATIONS USED 

A.O. 1950  ……………………………… 
Cl.  …………………………………. . … 
Ins.  …………………………………….. 
P.    ……………………………………… 
Pt.  ……………………………………… 
Reg.  ………………………………........ 
Rep.  …………………………………… 
S.  ……………………………………… 
Sch. ……………………………………. 
Sec.  ………………………………......... 
Subs.  …………………………………… 
w.e.f.  …………………………………… 

For  Adaptation of Laws Order, 1950 
Clause 
‖ 
Inserted 
‖ 
Page 
‖ 
Part 
‖ 
Regulation 
‖ 
Repealed 
‖ 
Section 
‖ 
Schedule 
‖ 
Section 
‖ 
‖ 
Substituted 
‖  With effect from 

CONTENTS 

Pages

The Drugs and Cosmetics Act, 1940   (23 of 1940)  ………….     1−30 

The Drugs and Cosmetics Rules, 1945  ……. . . ……………...   31−546 

2 

 
 
 
 
 
 
 
 
 
 
 
 
THE DRUGS AND COSMETICE ACT, 1940 

iii 

CHAPTER I 

INTRODUCTORY 

Sections 

1.        Short title, extent and commencement. 

2.        Application of other laws not barred. 

3.        Definitions. 

3A.  Construction of references to any law not in force or any 

functionary not in existence in the State of Jammu and Kashmir. 

4.        Presumption as to poisonous substances. 

CHAPTER II 

THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY 
AND THE DRUGS CONSULTATIVE COMMITTEE 

5.        The Drugs Technical Advisory Board. 

6.        The Central Drugs Laboratory. 

7.        The Drugs Consultative Committee. 

7A. 

Sections  5 and 7 not to apply to Ayurvedic, Siddha or Unani 
drugs. 

CHAPTER III 

IMPORT OF DRUGS AND COSMETICS 

8.        Standards of quality. 

9.        Misbranded drugs. 

9A.      Adulterated drugs. 

9B.       Spurious drugs. 

9C.       Misbranded cosmetics. 

9D.      Spurious cosmetics. 

10.       Prohibition of import of certain drugs or cosmetics. 

10A.  Power of Central Government to prohibit import of drugs and 

cosmetics in public interest. 

11.       Application of law relating to sea customs and powers of 

Customs officers. 

12.       Power of Central Government to make rules. 

13.       Offences. 
14.       Confiscation. 
15.       Jurisdiction.

3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

CHAPTER IV 

MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND 
COSMETICS 

Sections 

16.       Standards of quality. 
17.       Misbranded drugs. 
17A.     Adulterated drugs. 
17B.      Spurious drugs. 
17C.      Misbranded cosmetics. 
17D.     Spurious cosmetics. 
18. 

Prohibition of manufacture and sale of certain drugs 
and cosmetics. 

18A.     Disclosure of the name of the manufacturer, etc. 
18B.      Maintenance of records and furnishing of information. 
19.       Pleas. 
20.       Government Analysts. 
21.       Inspectors. 
22.       Powers of Inspectors. 
23.       Procedure of Inspectors. 
24. 

Persons bound to disclose place where drugs or cosmetics 
are manufactured or kept. 
25.       Reports of Government Analysts. 
26.       Purchaser of drug or cosmetic enabled to obtain test or analysis. 
26A.  Power of Central Government to prohibit manufacture, etc., 

27. 

of drug and cosmetic in public interest. 
Penalty for manufacture, sale, etc., of drugs in contravention 
of this Chapter. 

27A.  Penalty for manufacture, sale, etc., of cosmetics in 

contravention of this Chapter. 

28.       Penalty for non-disclosure of the name of the manufacturer, etc. 
28A.  Penalty for not keeping documents, etc., and for non-disclosure 

of information. 

28B.  Penalty for manufacture, etc. of drugs or cosmetics 

in contravention of section 26A. 

29.       Penalty for use of Government Analyst‘s report for advertising. 
30.       Penalty for subsequent offences. 
31.       Confiscation. 
31A.     Application of provisions to Government departments. 
32.       Cognizance of offences. 
32A.     Power of Court to implead the manufacturer, etc. 
33.       Power of Central Government to make rules. 
33A.     Chapter not to apply to Ayurvedic, Siddha or Unani drugs. 

CHAPTER IV A 

PROVISIONS RELATING TO AYURVEDIC SIDDHA AND UNANI DRUGS 

33B.     Application of Chapter IV A. 

4 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

Sections 

33C.         Ayurvedic, Siddha and Unani Drugs Technical 

Advisory Board. 

33D.        The Ayurvedic, Siddha and Unani Drugs Consultative 

Committee. 

33E.         Misbranded drugs. 
33EE.       Adulterated drugs. 
33EEA.      Spurious drugs. 
33EEB.  Regulation of manufacture for sale of Ayurvedic, 

Siddha and Unani drugs. 

33EEC.      Prohibition of manufacture and sale of certain 
Ayurvedic, Siddha and Unani drugs. 
Power of Central Government to prohibit manufacture, 
etc., of Ayurvedic, Siddha or Unani drugs in public 
interest. 

33EED. 

33F.         Government Analysts. 
33G.        Inspectors. 
33H.        Application of provisions of sections 22, 23, 24 and 

33-I. 

25. 
Penalty for manufacture, sale, etc., of Ayurvedic, 
Siddha or Unani drugs in contravention of this 
Chapter. 

33J.         Penalty for subsequent offences. 
33K.        Confiscation. 
33L.         Application of provisions to Government departments. 
33M.        Cognizance of offences. 
33N.        Power of Central Government to make rules. 
33O.        Power to amend First Schedule. 

CHAPTER V 
MISCELLANEOUS 

33P.      Power to give directions. 
34.       Offences by companies. 
34A.     Offences by Government departments. 
34AA.    Penalty vexatious search or seizure. 

35.       Publication of sentences passed under this Act. 
36.       Magistrate‘s power to impose enhanced penalties. 
36A.     Certain offences to be tried summarily. 
37.       Protection of action taken in good faith. 
38.       Rules to be laid before Parliament. 

THE FIRST SCHEDULE. 

THE SECOND SCHEDULE.

5 

 
 
 
 
 
 
 
 
 
1                                                        Drugs and Cosmetics  Act, 1940 

THE DRUGS AND COSMETICS ACT, 1940 

(23 OF 1940)1

[10th   April, 1940.]

An Act to regulate the import, manufacture, distribution and sale of drugs 

[and cosmetics]; 

2

3

2

WHEREAS  it  is  expedient  to  regulate  the 
cosmetics];  
AND WHEREAS  the  Legislature  of  all  the  Provinces  have  passed  resolutions  in  terms  of  section  103 
of  the  Government  of  India  Act,  1935  (26  Geo.  5,  c.2),  in  relation  to  such  of  the  above-mentioned 
matters  and  matters ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act; 

[import,  manufacture,  distribution  and  sale]  of  drugs 

[and 

It is hereby enacted as follows:- 

CHAPTER I 

INTRODUCTORY

1. Short title, extent and commencement.⎯ (1) This Act may be called the Drugs 

2

[and Cosmetics] 

Act, 1940.

(2)  It extends to the whole of India 4[ * * *]. 
5 as  the 
(3)   It  shall  come  into  force  at  once;  but  Chapter  III  shall  take  effect  only  from  such  date
Central Government may, by notification in the Official Gazette, appoint in this behalf, and Chapter IV shall 
5  as  the  State  Government  may,  by  like  notification, 

take  effect  in  a  particular  State  only  from  such  date
appoint in this behalf: 

[Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take effect only from 
such date10 after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972), as 
the Central Government may, by notification in the Official Gazette, appoint in this behalf.] 

6

2. Application of other laws not barred.- The provisions of this Act shall be in addition to and not in 

derogation of, the Dangerous Drugs Act, 1930 (2 of 1930), and any other law for the time being in force. 

3.  Definitions.—In this Act, unless there is anything repugnant in the subject or context, 
7
[(a) ―8[Ayurvedic, Siddha or Unani] drug‖ includes all medicines intended for internal or external use 
8
for  or  in  the  diagnosis,  treatment,  mitigation  or  prevention  of 
[disease  or  disorder  in  human  beings  or 
animals,  and  manufactured]  exclusively  in  accordance  with  the  formulae  described  in,  the  authoritative 

9

books of 

[Ayurvedic, Siddha and Unani Tibb systems of medicine], specified in the First Schedule;] 
9
[(aa) ―the Board‖ means— 

9

9

[Ayurvedic,  Siddha  or  Unani]  drug,  the 

(i)  in  relation  to 
Drugs Technical Advisory Board] constituted under section 33C; and 
(ii) in relation to any other drug or cosmetic, the Drugs Technical Advisory Board 
constituted under section 5;] 

[Ayurvedic,  Siddha  and  Unani 

1. For Statement of Object and Reasons, see Gazette of India, 1940, Pt. V, p. 34; for the Report of the Select Committee, see ibid., p. 143. 

The Act has been applied to all the partially excluded areas in the State of  Orissa, see Orissa Government Notification No. 3358-LSG., dated the 25th
August, 1941. 

2. Ins. by Act 21 of 1962, s. 2 (w.e.f. 27-7-1964). 
3. Subs. by the A.O. 1950, for certain words. 
4. The words ―except the State of Jammu and Kashmir‖ omitted by Act 19 of 1972, s .2. (w.e.f. 31-5-1972). 
5   1st   April, 1947; see  Notifn. No. F. 28 (10) (3) 45-H (1), dated the 2nd September 1946, Gazette  of India, 1946, Pt. I, p.1349. 

Chapter IV came into force in the States of Delhi, Ajmer and Coorg on the 1st  April, 1947, see ibid., Chapters III and IV came into force in the 
States of Himachal  Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur on the 1st   April, 1953, vide Notification No. S.R.O. 
663, dated the 30th March, 1953, Gazette of India, Pt. II, Sec. 3, p. 451. 
Chapter IV came into force in the Union territory of Dadra and Nagar Haveli   w.e.f. 1st  August, 1968, see Notification No. ADM/Law/117(74), 
dated the 20th July, 1968, Gazette of India, Pt. III, Sec. 3,  p.128. The Act is extended to Dadra and Nagar Haveli  by Reg. 6 of 1963, s. 2 and Sch. 
I; to Pondicherry by Reg. 7 of 1963. s. 3   and Sch. I; to Goa, Daman and Diu by Reg. 11 of 1963, s. 3 and Sch. and to Laccadive, Minicoy and 
Amindivi Islands by Reg. 8 of 1965. s.3 and Sch. 

6.   Added by Act 19 of 1972, s. 2. 
7    Ins. by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964). 
8.   Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
9.   Clause. (a) was relettered as cl. (aa) by Act 13 of 1964 s.  2, (w.e.f. 15-9-1964). 
10. 24th August, 1974, vide notifin no. S.O. 2185, dt. 9th August, 1974.

6 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1

[

2
[(aaa)]  ―cosmetic‖  means  any  article  intended  to  be  rubbed,  poured,  sprinkled  or    sprayed  on,  or 
introduced  into, or  otherwise  applied  to,  the  human  body  or  any  part  thereof  for  cleansing,  beautifying, 
promoting  attractiveness,  or altering the appearance, and includes any article intended for use as a component 

of cosmetic 

4

3
[* * *] ;] 

[(b) ―drug‖ includes— 

5
[(i)  all  medicines  for  internal  or  external  use  of  human  beings  or  animals  and  all  substances 
intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder 
in human beings or animals, including preparations applied on human body for the purpose of repelling 
insects like mosquitoes;] 

(ii) such substances (other than food) intended to affect the structure or any function of the human 

6

body  or intended to  be  used  for  the  destruction  of 
[vermin]  or  insects  which  cause  disease  in  human 
beings or animals, as may be specified from time to time by the Central Government by notification in 
the Official Gazette;] 

7
[(iii) all substances intended for use as components of a drug including empty gelatin capsules; and 
(iv)  such  devices*  intended  for  internal  or  external  use  in  the  diagnosis,  treatment,  mitigation  or 
prevention of disease or disorder in human beings or animals, as may be specified from time to time by 
the Central Government by notification in the Official Gazette, after consultation with the Board;] 

8

[(c) ―Government Analyst‖ means— 

9

(i)  in  relation to 
Central Government or a State Government under section 33F; and 
(ii) in relation to any other drug or cosmetic, a Government Analyst appointed by the Central 

[Ayurvedic,  Siddha  or  Unani]  drug,  a  Government  Analyst  appointed  by  the 

Government or a State Government under section 20;] 

10

[*  *  *  *   *] 

11

[(e) ―Inspector‖ means— 

9

(i) in relation to 

[Ayurvedic, Siddha or Unani] drug, an Inspector appointed by the Central 

Government or a State Government under section 33G; and 

(ii) in relation to any other drug or cosmetic, an Inspector appointed by the Central Government 
or a State Government under section 21;] 

13

12
[

14

[(f)]  ―manufacture‖  in  relation  to  any  drug 
[or  cosmetic]  includes  any  process  or  part  of  a 
process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise 

14

15

treating or adopting any drug 
include the compounding or dispensing  
the ordinary course of retail business; and ―to manufacture‖ shall be construed accordingly;] 

[sale or distribution] but does not 
[of any drug, or the packing of any drug or cosmetic,] in 

[or cosmetic] with a view to its 

16

17[(g)]  ―to  import‖,  with  its  grammatical  variations  and  cognate  expressions  means  to  bring  into 

18[India]; 

1.      Ins.  by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964). 
2.     Clause. (aa) relettered by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964). 
3.    omitted by Act 68 of 1982, s.3, certain words. 
4.    Subs. by Act 11 of 1955, s. 2, for cl. (b). 
5.    Subs. by Act 68 of 1982, s. 3 (w.e.f. 1-2-1983). 
6.    Subs. by  Act 13 of 1964, s. 2,  for  ―vermins‖ (w.e.f. 15-9-1964). 
7.    Ins. by Act 68 of 1982, s.3  (w.e.f. 1-2-1983). 
      The Central Government has specified (vide S.O. 1468 (E), dated 6-10-2005) the following devices intended for external or internal use in human 

beings or drugs with immediate effect, namely:- 

      (i) Cardiac Stents           (ii) Drug Eluding Stents       (iii) Catheters       (iv) Intra Ocular Lenses          (v) I.V. Cannulac              (vi) Bone Cements 
      (vii) Heart Valves          (viii) Scalp Vein Set              (ix) Orthopaedic Implants      (x) Internal Prosthetic Replacements 
8.    Subs. by Act 13 of 1964, s. 2, for cl. (c) (w.e.f.15-9-1964). 
9.    Subs. by Act 68 of 1982 s.2, for ―Ayurvedic (including sidda) or Unani‖ (w.e.f. 1-2-1983). 
10.  Cl. (d) omitted by Act 19 of 1972, s. 3.                                             15.  Subs. by  Act 68 of 1982, s.3, for  ―sale and distribution‖(w.e.f. 1-2-1983). 
11.  Subs. by Act 13 of 1964, s. 2, for cl. (e) (w.e.f. 15-9-1964).             16.  Subs. by Act 21 of 1962 s. 4,  for ―or  the packing of any drug‖. 
12.  Ins. by Act 11 of 1955,  s. 2.                 17.  Cls.(c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961). 
13.  Clause. (bbb) relettered as cl. (f) by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).   
14.  Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).                                 18.  Subs. by Act 3 of 1951, s. 3 and Sch., for  ―the States‖. 

7 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1

2
[(h)] ―patent or proprietary medicine‖ means,— 

[

(i)  in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all    formulations containing only 
such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani 
Tibb  systems  of  medicine  specified  in  the  First  Schedule,  but  does  not  include  a  medicine  which  is 
administered  by  parenteral  route  and  also  a  formulation  included  in  the  authoritative  books  as  specified  in 
clause (a); 

(ii) in relation to any other systems  of  medicine,  a  drug which is  a remedy or prescription  presented in 
a form ready for internal or external administration of human beings or animals and which is not included in 
the  edition  of  the  Indian  Pharmacopoeia  for  the  time  being  or  any  other  Pharmacopoeia  authorised  in  this 
behalf by the  Central  Government  after  consultation  with  the  Drugs  Technical  Advisory  Board  constituted 
under section 5;] 

2

3
[

[(i)] ―prescribed‖ means prescribed by rules made under this Act.] 

4

[*   *     *   *    *] 

5

[3A. Construction of references to any law not in force or any functionary  not in existence in the 
State  of  Jammu  and  Kashmir.—Any  reference  in  this  Act  to  any  law  which  is  not  in  force,  or  any 
functionary not in existence, in the State of Jammu and Kashmir, shall, in relation to that State, be construed 
as  a  reference  to  the  corresponding  law  in  force,  or  to  the  corresponding  functionary  in  existence,  in  that 
State.] 

4. Presumption as to poisonous substances.—Any substance specified as poisonous by rule made under 
6
[or Chapter IVA] shall be deemed to be a poisonous substance for the purposes of 
[or Chapter IVA], as the case may be. 

Chapter III or Chapter IV 
6
Chapter III or Chapter IV 

CHAPTER II 

THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABOURATORY 

AND THE DRUGS CONSULTATIVE COMMITTEE 

5.  The  Drugs  Technical  Advisory  Board.—(1)  The  Central  Government  shall,  as  soon  as  may  be, 
constitute  a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and 
the  State  Governments on technical matters arising out of the administration of this Act and to carry out the 
other functions assigned to it by this Act. 

7

[(2) The Board shall consist of the following members, namely:— 

(i) the Director General of Health Services, ex officio, who shall be Chairman; (ii) the Drugs 
Controller, India, ex officio; 
(iii) the Director of the Central Drugs Laboratory, Calcutta, ex officio;  
(iv) the Director  of the Central Research Institute, Kasauli, ex officio; 
(v) the Director of Indian Veterinary Research Institute, Izatnagar, ex officio; 
(vi) the President of Medical Council of India, ex officio; 
(vii) the President of the Pharmacy Council of India, ex officio; 
(viii) the Director of Central Drug Research Institute, Lucknow,  ex officio; 
(ix) two persons to be nominated by the Central Government from among persons who are in 

charge of drugs control in the States; 

1. Subs. by Act 68 of 1982, s. 3, for cl. (h) (w.e.f. 1-2-1983). 
2. Cls. (c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2  (w.e.f. 16-3-1961). 
3. Subs. by Act 11 of 1955, s. 2, for  cl. (e). 
4.  Clause. (f) ins. by the A.O. 1950 and omitted by Act 3 of 1951, s. 3 and Sch. 
5.  Ins. by Act 19 of 1972, s. 4 (w.e.f. 31-5-1972). 
6.  Ins. by Act 13 of 1964, s. 3 (w.e.f. 15-9-1964). 
7.  Subs. by Act 13 of 1964, s. 4,  for sub-section (2) (w.e.f. 15-9-1964).

8 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(x)  one person, to be elected by the Executive Committee of the Pharmacy Council of India, from 
among  teachers  in  pharmacy  or  pharmaceutical  chemistry  or  pharmacognosy    on  the  staff  of  an 
Indian university or a college affiliated thereto; 

(xi) one person, to be elected by the Executive Committee of the Medical Council of India, from 
among teachers in medicine or therapeutics on the staff of  an Indian university or a college affiliated 
thereto; 

(xii) one person to be nominated by the Central Government from the  pharmaceutical industry; 

(xiii) one pharmacologist to be elected by the Governing Body of the Indian Council of  Medical 
Research;  

(xiv) one person to be elected by the Central Council of the Indian Medical Association; 

(xv) one person to be elected by the Council of the Indian Pharmaceutical Association; 

(xvi) two persons holding the appointment of Government Analyst under this Act, to be 
nominated by the Central Government.] 

(3)  The  nominated  and  elected  members  of  the  Board  shall  hold  office  for  three  years,  but  shall  be 

eligible for re- nomination and re-election: 

1

[Provided that the person nominated or elected, as the case may be, under clause (ix) or clause (x) or 
clause (xi) or clause (xvi) of sub-section (2) shall hold office for so long as he holds the appointment of the 
office by virtue of which he was nominated or elected to the Board.] 

(4) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a 

quorum and regulating its own procedure and the conduct of all business to be transacted by it. 

(5) The Board may constitute sub-committees and may appoint to such sub-committees for such periods, 
not  exceeding  three  years,  as  it  may  decide,  or  temporarily  for  the  consideration  of  particular  matters, 
persons who are not members of the Board. 

(6) The functions of the Board may be exercised notwithstanding any vacancy therein. 

(7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the 

Board with such clerical and other staff as the Central Government considers necessary. 

6. The Central Drugs Laboratory.—(1) The Central Government shall, as soon as may be, established 
a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to 
carry out the functions entrusted to it by this Act or any rules made under this Chapter: 

Provided that, if the Central Government so prescribes, the functions of the Central Drugs Laboratory in 
[or cosmetic or class of cosmetics] shall be carried out at the Central 
respect of any drug or class of drugs 
Research  Institute, Kasauli,  or  at any  other  prescribed  Laboratory  and the functions of  the  Director  of the 
Central  Drugs  Laboratory  in  respect  of  such  drug  or  class  of  drugs 
[or  such  cosmetic  or  class  of 
cosmetics]  shall  be  exercised  by  the  Director  of that Institute or of that other Laboratory, as the case may 
be. 

2

2

(2) the Central Government may, after consultation with the Board, make rules prescribing— 

3

(a)   the functions of the  Central Drugs Laboratory; 

[*   *  *    *   *] 

(d)  the  procedure  for  the  submission  to  the  said  Laboratory 

4
[under  Chapter  IV  or  Chapter  IVA]  of 

[or cosmetics] for analysis or test, the forms of Laboratory‘s reports thereon and the 

2

samples of drugs 
fees payable in respect of such reports; 

1.  Subs. by Act 13 of 1964, s. 4, for the proviso (w.e.f. 15-9-1964). 
2.  Ins. by Act 21 of 1962, s. 5 (w.e.f. 27-7-1964). 
3.  Cls. (b) and (c) omitted by Act 11 of 1955, s. 4. 
4.  Subs. by Act 13 of 1964, s. 5, for ―under Chapter IV‖ (w.e.f. 15-9-1964).

9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(e) such  other  matters  as may  be  necessary  or  expedient  to  enable  the said  Laboratory  to 

carry  out  its functions; 

(f) the matters necessary to be prescribed for the purposes of the proviso to sub-section (1). 

7.  The  Drugs  Consultative  Committee.—(1)  The  Central  Government  may  constitute  an  advisory 
committee  to  be  called  ―the    Drugs  Consultative  Committee‖  to  advise  the  Central  Government,  the  State 
Governments  and  the  Drugs  Technical  Advisory  Board  on  any  other  matter  tending  to  secure  uniformity 
throughout 

1
[India] in the administration of this Act. 

(2)  The    Drugs    Consultative    Committee    shall    consist    of  two    representatives    of    the    Central  
Government  to  be nominated  by  that  Government  and  one  representative  of  each  State  Government  to  
be  nominated  by  the  State Government concerned. 

(3) The Drugs Consultative Committee shall meet when required to do so by the Central Government and 

shall have power to regulate its own procedure. 

2[7A.  Sections  5  and  7  not  to  apply  to  Ayurvedic,  Siddha  or  Unani  drugs.—Nothing  contained  in 

sections 5 and 7 shall apply to 3[Ayurvedic, Siddha or Unani] drugs.] 

4

CHAPTER III 

[IMPORT OF DRUGS AND COSMETICS] 

5
8. Standards of quality.—
[(1) For the purposes of this Chapter, the expression ―standard quality‖ 
means— 

(a)  in relation to a  drug, that the drug complies with the standard  set out in 
and 
(b)  in relation to a cosmetic, that the cosmetic compiles with such standard as may be 
prescribed]. 

6
[the Second Schedule], 

(2)  The  Central  Government,  after  consultation  with  the  Board  and  after  giving  by  notification  in  the 
Official Gazette not less than three months‘ notice of its intention so to do, may by a like notification add to or 
otherwise amend 
[the  Second 
Schedule]  shall  be  deemed  to  be amended accordingly. 

[the Second  Schedule],  for  the  purposes  of  this  Chapter,  and  thereupon 

6

6

7

[9. Misbranded drugs.—For the purposes of this Chapter a drug shall be deemed to be misbranded— 

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to 

appear of better or greater therapeutic value than it really is; or 

(b) if it is not labelled in the prescribed manner; or 

(c) if its label or container or anything accompanying the drug bears any statement, design or 

device which makes any false claim for the drug or which is false or misleading in any particular.] 

8

[9A. Adulterated drugs.— For the purposes of this Chapter, a drug shall be deemed to be adulterated.— 

(a)   if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or 
(b)    if  it  has  been  prepared,  packed  or  stored  under  insanitary  conditions  whereby  it  may  

have  been contaminated with filth or whereby it may have been rendered injurious to health; or 

1.  Subs. by Act 3 of 1951, s. 3 and Sch., for  ―the States‖. 

2.  Ins. by Act 13 of 1964, s. 6 (w.e.f. 15-9-1964). 
3.  Subs. by Act 68 of 1982, s. 2  for certain words (w.e.f. 1-2-1983). 
4.  Subs. by Act 68 of 1982, s. 4,  for ―IMPORT OF DRUGS‖ (w.e.f. 1-2-1983). 
5.  Subs. by Act 21 of 1962, s. 6, for sub-section (1) (w.e.f. 27-7-1964). 
6.  Subs. by Act 13 of 1964, s. 7, for  ―the Schedule‖ (w..e.f. 15-9-1964). 
7.  Subs. by Act 68 of 1982, s. 5, for s.  9 (w.e.f. 1-2-1983). 
8.  Subs. by Act 68 of 1982, s. 6, (w.e.f. 1-2-1983).

10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(c)      if  its  container  is  composed  in  whole  or  in  part,  of  any  poisonous  or  deleterious  substance 

which may render the contents injurious to health; or 

(d)   if it bears or contains, for purposes of colouring only, a colour other than one which is 

prescribed; or 

(e)    if it contains any harmful or toxic substance which may render it injurious to health; or 
(f)    if any substance has been mixed therewith so as to reduce its quality or strength. 

9B. Spurious drugs.— For the purposes of this Chapter, a drug shall be deemed to be spurious— 

(a)   if it is imported under a name which belongs to another drug; or 
(b)   if it is an imitation of, or a substitute for, another drug or resembles another drug in a manner 
likely to deceive  or  bears  upon  it  or  upon  its  label    or  container  the  name  of  another  
drug  unless  it  is  plainly  and conspicuously marked so as to reveal its true character and its 
lack of identity with such other drug; or 

(c)   if the label or the container bears the name of an individual or company purporting to be the 

manufacturer of the drug, which individual or company is fictitious or does not exist; or 

(d)   if it has been substituted wholly or in part by another drug or substance; or 
(e)   if it purports to be the product of a manufacturer of whom it is not truly a product. 

9C. Misbranded cosmetics.—For the purposes of this chapter, a cosmetic shall be deemed to be 
misbranded— 

(a) if it contains a colour which is not prescribed; or 

(b) if it is not labelled in a prescribed manner; or 

(c)  if  the  label  or  container  or  anything  accompanying  the  cosmetic  bears  any  statement  which  is 

false or misleading in any particular. 

9D. Spurious cosmetics.—For the purposes of this Chapter, a drug shall be deemed to be spurious,— 

(a) if it is imported under the name which belongs to another cosmetic; or 

(b) if it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a 
manner  likely  to  deceive  or  bears  upon  it  or  upon  its  label  or  container  the  name  of  another  cosmetic, 
unless it is plainly or conspicuously marked so as to reveal its true character and its lack of identity with 
such other cosmetic; or 

(c)  if  the  label  or  the  container  bears  the  name  of  an  individual  or  company  purporting  to  be  the 

manufacturer of the cosmetic, which individual or company is fictitious or does not exist; or 

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.] 

10.  Prohibition  of  import  of  certain  drugs  or  cosmetics.— From  such  date
Central Government by notification in the Official Gazette in this behalf, no person shall import— 

1 as  may  be  fixed  by  the 

(a)   any drug 

2

[or cosmetic] which is not of standard quality; 

  3[(b) any misbranded drug 4[or misbranded or spurious cosmetic;] 

1.  1st April, 1947 for cls. (a), (b), (c), (e) and (f) and 1st April 1949 for cl. (d) see Notifn. No.18- 12/46-D (I), dated the 11th February 1947, Gazette of 

India, 1947, Pt. 1, P. 189 as amended by Notifn. No.F.1-2/48-D (1), dated  the 29th  September,1948. 
1st April, 1953 for the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal,Tripura, Vindhya Pradesh and Manipur; vide Notifn. No. S.R.O. 666, 
dated the 30th March, 1953, Gazette of India, 1953, Pt. II, Sec. 3, p.451. 

2.  Ins. by Act 21 of 1962, s. 8 (w.e.f. 27-7-1964). 
3.  Subs. by Act 21 of 1962, s. 8,  for cl. (b) (w.e.f. 27-7-1964). 
4.  Subs. by Act 68 of 1982, s.7, for ―or misbranded cosmetic‖ (w.e.f. 1-2-1983).

11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1

2

[(bb) any 

3

[adulterated or spurious] drug;] 

(c) any drug 

[or cosmetic] for the import of which a licence is prescribed, otherwise than under, and 

in accordance with, such licence; 

4[(d)  any  patent  or  proprietary  medicine,  unless  there  is  displayed  in  the  prescribed  manner  on  the 
label or container thereof  5[the true formula or list of active ingredients contained in it, together with the 
quantities thereof;] 

(e)  any  drug  which  by  means  of  any  statement,  design  or  device  accompanying  it  or  by  any 
other  means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other 
effect, as may be prescribed; 

3[(ee)  any  cosmetic  containing  any  ingredient  which  may  render  it  unsafe  or  harmful  for  use 

under  the directions indicated or recommended;] 

(f) any drug 3[or cosmetic] the import of which is prohibited by rule made under this Chapter: 

Provided that nothing in this section shall apply to the import, subject to prescribed conditions, of small 

quantities of any drug for the purpose of examination, test or analysis or for personal use: 

Provided further that the Central Government may, after consultation with the Board, by notification in the 
Official Gazette, permit, subject to any conditions specified in the notification, the import of any drug or class 
of drugs not being of standard quality. 

6

[*  * *  *  *] 
7

[10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest.—
Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that 
the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does 
not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no 
therapeutic  justification  and  that  in  the  public  interest  it  is  necessary  or  expedient  so  to  do  then,  that 
Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.] 

11. Application of law relating to sea customs and powers of Customs Officers.— (1) The law for the 
time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of 

the  Sea  Customs  Act,  1878  (8  of  1878)

  shall,  subject  to  the  provisions  of  section  13  of this  Act,  apply  in 

9

8

respect of drugs 

[and cosmetics] the import of which is prohibited under this Chapter, and officers of Customs 

and  officers  empowered  under  that  Act  to  perform  the  duties  imposed  thereby  on  a 

[Commissioners  of 

Customs]  and  other  officers  of  Customs,  shall  have  the  same  powers  in  respect  of  such  drugs 
cosmetics]  as  they  have  for  the  time  being  in  respect  of  such  goods  as aforesaid. 

11

10

[(2)  Without  prejudice  to  the  provisions  of  sub-sections  (1),  the 

[Commissioners  of  Customs]  any 
officer  of  the  Government  authorized  by  the  Central  Government  in  this  behalf,  may  detain  any  imported 
[or  cosmetic]  the  import  of  which  is  prohibited  under  this 
package  which  he  suspects  to  contain  any  drug 
Chapter and shall forthwith report such detention to the Drugs Controller, India, and, if necessary, forward the 
package or sample of any suspected drug 

[or cosmetic] found therein to the Central Drugs Laboratory.] 

9

9

9

[and 

10

12.  Power  of  Central  Government  to  make  rules.—(1)  The  Central  Government  may, 

[after 
consultation with or on  the  recommendation  of  the  Board]  and  after  previous  publication  by  notification  in 
the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter: 

12

1.    Ins. by Act 13 of 1964, s. 9 (w.e.f. 15-9-1964). 
2.    Subs. by Act 68 of 1982, s.7, for ―adulterated‖ (w.e.f. 1-2-1983). 
3.    Ins. by Act 21 of 1962, s. 8 (w.e.f. 27-7-1964). 
4.    Subs. by Act 11 of 1955, s. 5, for cl. (d). 
5.    Subs. by Act 68 of 1982, s.7, for certain words (w.e.f. 1-2-1983). 
6.    Explanation omitted by s.7, ibid. (w.e.f. 1-2-1983). 
7.    Ins. by s. 8, Act 68 of 1982. (w.e.f. 1-2-1983). 
8.    Now see the Customs Act, 1962. 
9.    Ins. by Act 21of 1962, s. 9 (w.e.f. 27-7-1964). 
10.  Subs. by Act 22 of 1995, s. 83, for ―Customs Collector‖. 
11.  Subs. by Act 11 of 1955, s. 6, for sub-section (2). 
12.  Subs. by Act 68 of 1982, s.9, for certain words (w.e.f. 1-2-1983).

12 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1

[Provided  that  consultation  with  the  Board  may  be  dispensed  with  if  the  Central  Government  is  of 
opinion that circumstances  have  arisen  which  render  it  necessary  to  make  rules  without  such  consultation, 
but  in  such  a  case  the Board shall be consulted within six months of the making of the rules and the Central 
Government  shall  take  into  consideration  any  suggestions  which  the  Board  may  make  in  relation  to  the 
amendment of the said rules.] 

(2) Without prejudice to the generality of the forgoing power, such rules may— 

2

3

(a)   specify the drugs or classes of drugs 

[or cosmetics or classes of cosmetics] for the import of 

which  a  licence  is  required, 
[and  prescribe  the  form  and  conditions  of  such  licences,  the  authority 
empowered to issue the same, the fees payable therefor and provide for the cancellation, or suspension of 
such licence in any case where any provision of this Chapter or the rules made thereunder is contravened 
or any of the conditions subject to which the licence is issued is not complied with]; 

(b)   prescribe  the  methods  of  test  or  analysis  to  be  employed  in  determining  whether  a  drug 

cosmetic] is of standard quality; 

(c)   prescribe,   in   respect   of   biological   and   organometallic   compounds,   the   units   or   

2

[or 

methods   of standardization; 

4
[(cc)  prescribe  under  clause  (d)  of 

contain for purposes or colouring;] 

5
[section  9A]  the  colour  or  colours  which  a  drug  may  bear  or 

(d)  specify the diseases or ailments which an imported drug may not purport or claim 

cure or mitigate] and such other effects which such drug may not purport or claim to have; 

(e)    prescribe  the  conditions  subject  to  which  small  quantities  of  drugs,  the  import  of  which  is 
otherwise  prohibited  under  this  Chapter,  may  be  imported  for  the  purpose  of  examination,  test  or 
analysis or for personal use; 

6
[to prevent, 

2
[or  cosmetics]  may  be  imported,  and  prohibit  their 

(f)      prescribe  the  places  at  which  drugs 

import  at  any other place; 

(g)    require  the  date  of  manufacture  and  the  date  of  expiry  of  potency  to  be  clearly  and  truly 
stated  on  the label or container of any specified imported drug or class of such drug, and prohibit the 
import  of  the  said  drug  or  class  of  drug  after  the  expiry  of  a  specified  period  from  the  date  of 
manufacture; 

2

[or  
(h)    regulate    the    submission    by    importers,    and    the    securing,    of    samples    of    drugs   
cosmetics]  for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if 
any, payable for such examination, test or analysis; 

(i)    prescribe  the  evidence  to  be  supplied,  whether  by  accompanying  documents  or  otherwise,  of 
the  quality of  drugs  2[or  cosmetics]  sought  to  be  imported,  the  procedure  of  officers  of  Customs 
in  dealing  with  such evidence, and the manner of storage at places of import of drugs  2[or cosmetics] 
detained pending admission; 

(j)    provide  for  the  exemption,  conditionally  or  otherwise,  from  all  or  any  of  the  provisions  of 
2
[or cosmetics] imported for the  purpose only  of 

this  Chapter and  the rules made  thereunder  of  drugs 
transport through, an export from, 

[India]; 

7

(k)    prescribe the conditions to be observed in the packing in bottles, packages or other containers, 
of  imported  drugs  2[or  cosmetics]  8[including  the  use  of  packing  material  which  comes  into  direct 
contact with the drugs]; 

2

(l)      regulate  the  mode  of  labeling  drugs 

[or  cosmetics]  imported  for  sale  in  packages,  and 

prescribe  the matters which shall or shall not be included in such labels; 

(m)  prescribe  the  maximum  proportion  of  any  poisonous  substance  which  may  be  added  to  or 
contained  in any imported drug, prohibit the import of any drug in which that proportion is exceeded, 
and specify substances which shall be deemed to be poisonous for the purposes of this Chapter and the 
rules made thereunder; 

1.  Ins. by Act 11 of 1955, s. 7. 
2.  Ins. by Act 21of 1962, s. 10 (w.e.f. 27-7-1964). 
3.  Subs. by Act 68 of 1982, s. 9, for certain words (w.e.f. 1-2-1983). 
4.  Ins. by Act 13 of 1964, s. 10 (w.e.f. 15-9-1964). 
5.  Subs. by Act 68 of 1982, s. 9, for ―section 9B‖ (w.e.f. 1-2-1983). 
6.  Subs. by Act 11 of 1955, s. 7, for  ―to cure or mitigate‖. 
7.  Subs. by Act  3 of 1951, s. 3 and Sch., for ―the States‖. 
8.  Ins. by Act 68 of 1982, s. 9 (w.e.f. 1-2-1983).

13 

 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(n)    require  that  the  accepted  scientific  name  of  any  specified  drug  shall  be  displayed  in  the 
prescribed manner on the  label or wrapper of any imported, patent or proprietary  medicine  containing 
such drug;  

(o)   provide for the exemption, conditionally or otherwise, from all or any of the provisions of this 
Chapter or the rules made thereunder, of any specified drug or class of drugs  1[or cosmetic or class of 
cosmetics]. 

2[13. Offences.—(1) Whoever himself or by any other person on his behalf imports, — 

(a) any drug deemed to be adulterated under section 9A or deemed to be a spurious drug under section 
9B or any spurious cosmetic referred to in section 9D or any cosmetic of the nature referred to in clause (ee) 
of  section 10 shall be punishable with imprisonment for a term which may extend to three years and a fine 
which may extend to five thousand rupees; 

(b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the import of which is 
prohibited under section 10, or any rule made under this Chapter, shall be punishable with imprisonment for a 
term which may extend to six months, or with fine which may extend to five hundred rupees,  or with both; 

(c) any drug or cosmetic in contravention of the provisions of any notification issued under section 10A, 
shall be punishable with imprisonment for a term which may extend to three years, or with fine which may 
extend to five thousand rupees, or with both; 

(2) Whoever having been convicted of an offence— 
(a) under clause (a) or clause (c) of sub-section (1), is again convicted of an offence under that clause, 
shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to  five  years,  or  with  fine  which  may 
extend to ten thousand rupees, or with both; 

(b)  under  clause  (b)  of  sub-section  (1),  is  again  convicted  of  an  offence  under  that  clause,  shall  be 
punishable with  imprisonment  for  a term  which  may  extend to one year,  or  with fine  which  may  extend  to 
one thousand rupees, or with both. 

(3) The punishment provided by this section shall be in addition to any penalty to which the offender 

may be liable under the provisions of section 11.] 

14.  Confiscation.—Where any offence punishable under section 13 has been committed, the consignment 
of the drugs 3[or cosmetics] in respect of which the offence has been committed shall be liable to confiscation. 

15. Jurisdiction.—No Court inferior to  that 

4
[of a Metropolitan Magistrate or of a Judicial Magistrate 

of the first class] shall try an offence punishable under section 13. 

CHAPTER IV 

MANUFACTURE, SALE AND DISTRIBUTION OF 

5

[DRUGS AND COSMETICS] 

16. Standards of quality.—

6
[(1) For the purposes of this Chapter, the expression ―standard quality‖ 

means—  

(a)    in  relation  to  a  drug,  that  the  drug  complies  with  the  standard  set  out  in 

Schedule], and  

7
[the  Second 

(b)    in  relation  to  a  cosmetic,  that  the  cosmetic  complies  with  such  standard  as  may  be 

prescribed.] 
8

[Central  Government],  after  consultation  with  the  Board  and  after  giving  by  notification  in 
(2)  The 
the  Official Gazette not less than three months‘ notice of its intention so to do, may by a like notification 
[the  Second  Schedule]  for  the  purposes  of  this  Chapter,  and  thereupon  7[the 

add to or otherwise amend 
Second Schedule] shall be deemed to be amended accordingly. 

7

1.  Ins. by Act 21 of 1962, s. 10 (w.e.f. 27-7-1964). 
2.  Subs. by Act 68 of 1982, s.10, for  s.13 (w.e.f. 1-2-1983). 
3.  Ins. by Act 21 of 1962, s. 11 (w.e.f. 27-7-1964). 
4.  Subs. by Act 68 of 1982, s. 11, for certain words  (w.e.f. 1-2-1983). 
5.  Subs. by Act 68 of 1982 for ―DRUGS‖ (w.e.f. 1-2-1983). 
6.  Subs. by Act 21 of 1962, s. 12, for sub-section (1)  (w.e.f. 27-7-1964). 
7.  Subs. by Act  13 of 1964, s. 11, for ―the Schedule‖ (w.e.f 15-9-1964). 
8.  Subs. by Act 11 of 1955, s. 8, for ―State Government‖.

14 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1

[17. Misbranded drugs.—For the purposes of this Chapter, a drug shall be deemed to be misbranded,— 
(a)      if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to 

appear of betapeutic value than it really is; or 

(b)      if it is not labelled in the prescribed manner; or 
(c) if its label or container or anything accompanying the drug bears any statement, design or 
device which makes any false claim for the drug or which is false or misleading in any particular. 

17A.  Adulterated drugs.—For the purposes of this Chapter, a drug shall be deemed to be adulterated,— 

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or 
(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been 

contaminated with filth or whereby it may have been rendered injurious to health; or 

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which 

may render the contents injurious to health; or 

(d) if it bears or contains, for the purposes of colouring only, a colour other than one which is 
prescribed; or 
(e) if it contains any harmful or toxic substance which may render it injurious to health; or 
(f) if any substance has been mixed therewith so as to reduce its quality or strength. 

17B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be spurious,—  

(a) if it is manufactured under a name which belongs to another drug; or 
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner 
likely to deceive  or  bears  upon  it  or  upon  its  label  or  container  the  name  of    another  drug  unless  
it  is  plainly  and conspicuously marked so as to reveal its true character and its lack of  identity with such 
other drug; or 

(c)  if  the  label  or  container  bears  the  name  of  an  individual  or  company  purporting  to  be  the 

manufacturer of the drug , which individual or company is fictitious or does not exist; or 
(d) if it has been substituted wholly or in part by another drug or substance; or 
(e) if it purports to be the product of a manufacturer of whom it is not truly a product. 

17C.  Misbranded  cosmetics.—  For  the  purposes  of  this  Chapter,  a  cosmetic  shall  be  deemed  to  be 
misbranded, -- 

(a) if it contains a colour which is not prescribed; or 
(b) if it is not labelled in the prescribed manner; or 
(c)  if  the  label  or  container  or  anything  accompanying  the  cosmetic  bears  any  statement  which  is 

false or misleading in any particular. 

17D. Spurious cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,-- 
(a) if it is manufactured under a name which belongs to another cosmetic; or 

(b)  if  it  is  an  imitation  of,  or  a  substitute  for,  another  cosmetic  or  resembles  another  cosmetic  in 
a  manner likely to deceive or bears upon it or upon its label or container the name  of another cosmetic 
unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with 
such other cosmetic; or 

(c) if the label or container bears the name of an individual or a company purporting to be the 

manufacturer of the cosmetic which individual or company is fictitious or does not exist; or 
(d) if it purports to be the product of a manufacturer of whom it is not truly a product.] 

2[17E  Adulterated  cosmetics.-  For  the  purposes  of  this  Chapter,  a  cosmetic  shall  be  deemed  to  be 
adulterated,-  
(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or  
(b)  if  it  has  been  prepared,  packed  or  stored  under  insanitary  conditions  whereby  it  may  have  been 
contaminated with filth or whereby it may have been rendered injurious to health; or  
(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may 
render the contents injurious to health; or  
(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or  
(e) if it contains any harmful or toxic substance which may render it injurious to health; or  
(f) if any substance has been mixed therewith so as to reduce its quality or strength.] 

1.  Subs. by Act 68 of 1982, s.13, for s.17, 17A and 17B (w.e.f. 1-2-1983). 
2. Ins. by Act 26 of 2008, s 2 (w.e.f 10-8-2009)

15 

 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

18.  Prohibition  of  manufacture  and  sale  of  certain  drugs  and  cosmetics.—From  such   date  1as  may 
be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself 
or by any other person on his behalf— 

2
[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale] or 

(a)  
distribute— 

2
[(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious; 

12[(ii) any cosmetic which is not of a standard quality or is misbranded or  spurious;] 
3
[(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the 

[the true formula or list of active ingredients contained in it together with 

label or container thereof 
the quantities thereof];] 

2

(iv) any drug which by means of any statement, design or device accompanying it or by any other 
means, purports or claims  4[to prevent, cure or mitigate] any such disease or ailment, or to have any 
such other effect as may be prescribed; 

5[(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under 

the directions indicated or recommended; 

(vi)  any  drug  or  cosmetic  in  contravention  of  any  of  the  provisions  of  this  Chapter  or  any 

rule  made thereunder;] 

(b) 6[sell, or stock or exhibit or offer for sale,] or distribute any drug 7[or cosmetic] which has been 

imported or manufactured in contravention of any  of the provisions of this Act or any rule made 
thereunder; 

6

(c) 

[manufacture  for  sale  or  for  distribution,  or  sell,  or  stock  or  exhibit  or  offer  for  sale,]  or 

[or cosmetic], except under, and in accordance with the conditions of, a licence 

distribute  any  drug 
issued for such purpose under this Chapter: 

7

                     Provided  that  nothing  in  this  section  shall  apply  to  the  manufacture,  subject  to  prescribed 
conditions, of small quantities of any drug for the purpose of examination, test or analysis: 

8

Provided further that the 

[Central Government] may, after consultation with the Board, by notification in 
6
the Official Gazette, permit, subject to any conditions specified in the notification, the 
[manufacture for sale, 
or for distribution, sale, stocking or exhibiting or offering for sale] or distribution of any drug or class of drugs 
not being of standard quality. 

9

[*  *  *   * *] 
10

[18A.  Disclosure  of  the  name  of  the  manufacturer,  etc.—Every  person,  not  being  the  manufacturer 
of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the 
name, address and other particulars of the person from whom he acquired the drug or cosmetic.] 

11

[18B. Maintenance of records and furnishing of information.—Every person holding a licence under 
clause  (c)  of  section  18  shall  keep  and  maintain  such  records,  registers  and  other  documents  as  may  be 
prescribed  and  shall  furnish  to  any  officer  or  authority  exercising  any  power  or  discharging  any  function 
under  this  Act  such  information  as  is  required  by  such  officer  or  authority  for carrying out the purposes of 
this Act.] 

1.  1st April,1947 for sub-clauses (i), (ii), (iv) and (v) of clause (a) and clauses (b) and (c) ; 1st April, 1949 for sub-clause (iii) of clause (a) in so far as it 
takes  effect  in  Delhi,  Ajmer  and  Coorg,  see  Notifn.  No.  18-12/46-D.  II,  dated  the  11th  February,  1947.  Gazette  of  India,  1947,  Pt.  I,  p.189;  as 
amended  by  Notifn.  No.  F.  1-2/48-D(II),  dated  the  29th  September,  1948;  1st  April,  1953  for  the  States  of  Himachal  Pradesh,  Bilaspur,  Kutch, 
Bhopal, Tripura, Vindhya Pradesh and Manipur, vide Notifn. No. S.R.O. 664, dated the 30th March,1953, Gazette of India, 1953, Pt. II, Sec. 3, p. 
451. 

2.  Subs. by Act 68 of 1982, s.14, for certain words (w.e.f. 1-2-1983). 
3.  Subs. by Act 11 of 1955, s. 9, for sub-clause (iii). 
4.  Subs. by Act 11 of 1955, s. 9,  for ―to cure or mitigate‖. 
5.  Subs. by Act 21 of 1962, s. 14, for sub-clause (v) (w.e.f. 27-7-1964). 
6.  Subs. by Act 68 of 1982, s. 14, for certain words (w.e.f.1-2-1983). 
7.  Ins. by Act. 21 of 1962, s. 14 (w.e.f. 27-7-1964). 
8.  Subs. by Act 11 of 1955, s. 9, for ―State Government‖. 
9.  Explanation omitted by Act 68 of 1982, s.14 (w.e.f. 1-2-1983). 
10.  Ins. by Act 13 of  1964, s. 14 (w.e.f. 15-9-1964). 
11.  Ins. by Act 68 of 1982, s. 15  (w.e.f. 1-2-1983). 
12. Sub. by Act 26 of 2008, s 3, for sub-clause (ii) (w.e.f 10-8-2009), before substitution, stood as under : 
          ―any cosmetic which is not of a standard quality or is misbranded or spurious‖ 

16 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

19. Pleas.—(1) Save as hereinafter provided in this section, it shall be no defence in a prosecution under 
this Chapter to prove merely that the accused was ignorant of the nature, substance or quality of the drug 
1

[or  cosmetic]  in  respect  of  which  the  offence  has  been  committed  or  of  the  circumstances  of  its 
manufacture or import, or that a purchaser, having bought only for the purpose of test or analysis, has not 
been prejudiced by the sale. 

[For  the  purposes  of  section  18  a  drug  shall  not  be  deemed  to  be  misbranded  or 

2
[adulterated  or 
(2) 
spurious] or to be below standard quality nor shall a cosmetic be deemed to be misbranded or to be below 
standard quality] only by reason of the fact that— 

2

4

(a) there has been added thereto some innocuous substance or ingredient because the same is required 
[or  cosmetic]  as  an  article  of  commerce  in  a  state  fit  for 
[or cosmetic] or to 

for  manufacture  or  preparation  of  the  drug 
carriage or consumption, and not to increase the bulk, weight or measure of the drug 
conceal its inferior quality or other defects; or 

1

1

[*  * *  *  *] 
(b)  in  the  process  of  manufacture,  preparation  or  conveyance  some  extraneous  substance  has 
unavoidably become intermixed with it: Provided that this clause shall not apply in relation to any sale or 
distribution  of  the  drug  1[or  cosmetic]  occurring  after  the  vendor  or  distributor  became  aware  of  such 
intermixture. 
5[(3) A person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, 

shall not be liable for a contravention of section 18 if he proves— 

(a)    that  he  acquired  the  drug  or  cosmetic  from  a  duly  licensed  manufacturer,  distributor  or 
dealer thereof; 
(b)    that he did not know and could not, with reasonable diligence, have ascertained that the drug 

or cosmetic in any way contravened the provisions of that section; and 

(c)    that  the  drug  or  cosmetic,  while  in  his  possession,  was  properly  stored  and  remained  in  the 

same state as when he acquired it.] 

6

[20.Government  Analysts.—  (1)  The  State  Government  may,  by  notification  in  the  Official  Gazette, 
appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such 

areas in the state and in respect of such drugs or 
as may be specified in the notification. 

7

[classes of drugs or such cosmetics or classes of cosmetics] 

(2) The Central Government may also, by notification in the Official Gazette, appoint such persons as it 

thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or 
of drugs or such cosmetics or classes of cosmetics] as may be specified in the notification. 

7

[classes 

(3)  Notwithstanding  anything  contained  in  sub-section  (1)  or  sub-section  (2),  neither  the  Central 
Government nor a State Government shall appoint as a Government Analyst any official not serving under it 
without the previous consent of the Government under which he is serving. 

8

[(4) No  person  who  has  any  financial interest in  the  import,  manufacture  or sale  of  drugs  or  cosmetics 

shall be appointed to be a Government Analyst under sub-section (1) or sub-section (2) of this section.] 

21. Inspectors.—(1) The Central Government or a State Government may, by notification in the Official 
Gazette, appoint such persons  as  it thinks fit,  having  the  prescribed  qualifications,  to  be Inspectors for such 
areas as may be assigned to them by the Central Government or State Government, as the case may be. 

(2) The powers which may be exercised by an Inspector and the duties which may be performed by him, 
the  drugs  or  9[classes  of  drugs  or  cosmetics  or  classes  of  cosmetics]  in  relation  to  which  and  the 
conditions,  limitations  or  restrictions  subject  to  which,  such  powers  and  duties  may  be  exercised  or 
performed shall be such as may be prescribed. 

1.  Ins. by Act 21 of 1962, s.15 (w.e.f. 27-7-1964). 
2.  Subs. by Act 13 of 1964, s. 15, for certain words (w.e.f. 15-9-1964). 
3.  Subs. by Act 68 of 1982, s.16, for ―adulterated‖ (w.e.f. 1-2-1983). 
4.  Cl.(aa) ins. by Act 11 of 1955, s. 10 and omitted by Act 13 of 1964, s. 15 (w.e.f. 15-9-1964). 
5.  Subs.by Act 13 of 1964, s. 15, for sub-section (3) (w.e.f. 15-9-1964). 
6.  Subs. by Act 35 of 1960, s. 4, for ss. 20 and 21 (w.e.f. 16-3-1961). 
7. Subs. by Act 21 of 1962,  s. 16,  for ―class of drugs‖ (w.e.f. 27-7-1964). 
8.  Ins. by Act 68 of 1982, s.17 (w.e.f.1-2-1983). 
9.  Subs. by Act 21 of 1962, s.17, for ―class of drugs‖ (w.e.f. 27-7-1964).

17 

 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(3) No person who has any financial interest 
shall be appointed to be an Inspector under this section. 

1

[in the import, manufacture or sale of drugs or cosmetics] 

(4) Every Inspector shall be deemed to be public servant within the meaning of section 21 of the Indian 

Penal  Code  (45  of  1860),  and  shall  be  officially  subordinate  to  such  authority 
qualifications,] as the Government appointing him may specify in this behalf.] 

2
[having  the  prescribed 

3

[22.  Powers  of  Inspectors.—(1)  Subject  to  the  provisions  of  section  23  and  of  any  rules  made  by 
the  Central Government in this behalf, an Inspector may, within the local limits of the area for which he is 
appointed,— 

4

[(a) inspect,— 

(i) any premises wherein any drug or cosmetic is being manufactured and the means employed for 

standardising and testing the drug or cosmetic; 

(ii) any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or offered for 

sale, or distributed; 

(b)   take samples of any drug or cosmetic,— 

(i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is 

being distributed; 

(ii)  from  any  person  who  is  in  the  course  of  conveying,  delivering  or  preparing  to  deliver  such 

drug or cosmetic to a purchaser or a consignee; 

(c) at all reasonable times, with such assistance, if any, as he considers necessary,-- 

(i) search any person, who, he has reason to believe, has secreted about his  person, any drug  or 

cosmetic in respect of which an offence under this  Chapter has been, or is being, committed; or 

(ii) enter and search any place in which he has reason to believe that an offence under this Chapter 

has been, or is being, committed; or 

(iii) stop  and search any vehicle,  vessel or  other conveyance  which, he  has  reason to  believe, is 
being  used for  carrying  any  drug  or cosmetic in respect  of  which an  offence under this  Chapter  has 
been, or is being, committed, 

and order in writing the person in possession of the drug or cosmetic in respect of which the offence has 
been, or is being, committed, not to dispose of any stock of such drug or cosmetic for a specified period 
not exceeding twenty days, or, unless the alleged offence is such that the defect may be removed by the 
possessor of the drug or cosmetic, seize the stock of such drug or cosmetic and any substance or article by 
means  of  which  the  offence  has  been,  or  is  being,  committed  or  which  may  be  employed  for  the 
commission of such offence;] 

5

4

[(cc) examine any record, register, document or any other material object found 

[with any person, or 
in any place,  vehicle,  vessel  or  other  conveyance  referred  to in  clause  (c)],  and seize the  same  if  he  has 
reason  to  believe that  it  may  furnish  evidence  of  the  commission  of  an  offence  punishable  under  
this  Act  or  the  rules  made thereunder;] 

4

[(cca)  require  any  person  to  produce  any  record,  register,  or  other  document  relating  to  the 
manufacture for sale or for distribution, stocking, exhibition for sale, offer for sale or distribution of any 
drug or cosmetic in respect of which he has reason to believe that an offence under this Chapter has been, 
or is being, committed;] 

(d) exercise such other powers as may be necessary for carrying out the purposes of this Chapter or 

any rules made thereunder. 

1.  Subs. by  Act 21 of 1962, s.17, for ―in the manufacture, import or sale of drugs‖ (w.e.f 27-7-1964). 
2.  Ins. by Act 68 of 1982, s.18 (w.e.f. 1-2-1983). 
3.  Subs. by Act 11of 1955, s. 11, for s. 22. 
4.  Subs. by Act 68 of 1982, s.19, for certain words (w.e.f. 1-2-1983). 
5.  Ins. by Act 35 of 1960, s. 5 (w.e.f. 16-3-1961).

18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
[the  Code  of  Criminal  Procedure,  1973  (2  of  1974)]  shall,  so  far  as  may  be, 
apply  to  any  search  or  seizure  under  this  Chapter  as  they  apply  to  any  search  or  seizure  made  under  the 

(2)  The  provisions  of 

Drugs and Cosmetics Act, 1940 

authority of a warrant issued under 

[section 94] of the said Code. 

1

2

[(2A) Every record, register or other document seized under clause (cc) or produced under clause (cca) 
shall  be  returned  to  the  person,  from  whom  they  were  seized  or  who  produce  the  same,  within  a  period  of 
twenty  days  of  the  date  of  such  seizure  or  production,  as  the  case  may  be,  after  copies  thereof  or  extracts 
therefrom certified by that person, in such manner as may be prescribed, have been taken.] 

(3) If any person wilfully obstructs an Inspector in the exercise of the powers conferred upon him by or 

2

under this Chapter, 
[or  refuses  to  produce  any  record,  register  or  other  document  when  so  required  under 
clause  (cca)  of  sub- section (1),] he shall be punishable with imprisonment which may extend to three years, 
or with fine, or with both.] 

23. Procedure of Inspectors.—(1) Where an Inspector takes any sample of a drug 

3

[or cosmetic] under 

this Chapter, he shall tender the fair price thereof and may require a written acknowledgment therefor. 

(2) Where the price tendered under sub-section (1) is refused, or where the Inspector seizes the stock of 

any drug 

3
[or cosmetic] under clause (c) of section 22, he shall tender a receipt therefor in the prescribed form. 

(3) Where an Inspector takes a sample of a drug 

3
[or cosmetic] for the purpose of test or analysis, he shall 
intimate  such  purpose  in  writing  in  the  prescribed  form  to  the  person  from  whom  he  takes  it  and,  in  the 
presence  of  such  person  unless  he  wilfully  absents  himself,  shall  divide  the  sample  into  four  portions  and 
effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any 
of the portions so sealed and marked: 

Provided  that  where  the  sample  is  taken  from  premises  whereon  the  drug 

manufactured, it shall be necessary to divide the sample into three portions only: 

3
[or  cosmetic]  is  being 

Provided further that where the drug 

3

[or cosmetic] is made up in containers of small volume, instead of  

3

dividing a sample  as  aforesaid,  the  Inspector  may,  and  if  the  drug 
[or  cosmetic]  be  such  that  it  is  likely 
to  deteriorate  or  be otherwise damaged by exposure shall, take three or four, as the case may be, of the said 
containers after suitably marking the same and, where necessary, sealing them. 

(4) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to 

the person from whom he takes it, and shall retain the remainder and dispose of the same as follows:— 

(i) one portion or container he shall forthwith send to the Government Analyst for test or analysis; 

(ii) the second he shall produce to the Court before which proceedings, if any, are instituted in 

respect of the drug 3[or cosmetic]; 

4[(iii) the third, where taken, he shall send to the person, if any, whose name, address and other 

particulars have been disclosed under section 18A.] 

(5) Where an Inspector takes any action under clause (c) of section 22,— 
3

(a) he shall use all despatch in ascertaining whether or not the drug 

[or cosmetic] contravenes any of 

3
[or cosmetic] does not so contravene, 
the provisions of the section 18 and, if it is ascertained that the drug 
forthwith revoke the order passed under the said clause or, as the case may be, take such action as may be 
necessary for the return of the stock seized; 
3
[or  cosmetic],  he  shall  as  soon  as  may  be  inform 

(b)  if  he  seizes  the  stock  of  the  drug 
Magistrate] and take his orders as to the custody thereof; 
(c)  without  prejudice  to  the  institution  of  any  prosecution,  if  the  alleged  contravention  be  such  that 

[a  Judicial 

5

the  defect may be remedied by the possessor of the drug 
the defect has been so remedied, forthwith revoke his order under the said clause. 

3
[or cosmetic], he shall, on being satisfied that 

1.  Subs. by Act 68 of 1982, s.19, for ―the Code of Criminal Procedure, 1898‖ (w.e.f. 1-2-1983). 
2.  Ins. by Act 68 of 1982, s. 19. (w.e.f. 1-2-1983). 
3.  Ins.by Act 21 of 1962, s.15 (w.e.f. 27-7-1964). 
4.  Subs. by Act 13 of 1964, s.16, for cl. (iii) (w.e.f.15-9-1964). 
5.   Subs. by Act 68 of 1982, s. 20, for ―a Magistrate‖  (w.e.f. 1-2-1983).

19 

 
 
 
 
 
 
 
 
 
 
 
 
 
3

1

[(6) Where  an  Inspector seizes any record, register, document  or any  other  material object  under clause 
(cc) of sub- section (1) of section 22, he shall, as soon as may be, inform  2[a Judicial Magistrate] and take his 
orders as to the custody thereof.] 

Drugs and Cosmetics Act, 1940 

24.  Persons  bound  to  disclose  place  where  drugs  or  cosmetics  are  manufactured  or  kept.  —Every 
person for the time being in charge of any premises whereon any drug 3[or cosmetic] is being manufactured or 
is kept for sale or distribution shall, on being required by an Inspector so to do, be legally bound to disclose to 
the Inspector the place where the drug 3[or cosmetic] is being manufactured or is kept, as the case may be. 

[or 
25. Reports of Government Analysts.—(1) The Government Analyst to whom a sample of any drug  
cosmetic]  has  been  submitted  for  test  or  analysis  under  sub-section  (4)  of  section  23,  shall  deliver  to  the 
Inspector submitting it a signed report in triplicate in the prescribed form. 

(2)  The  Inspector  on  receipt  thereof  shall  deliver  one  copy  of  the  report  to  the  person  from  whom  the 
sample  was taken  4[and  another  copy  to  the  person,  if  any,  whose  name,  address  and  other  particulars  have 
been disclosed under section 18A], and shall retain the third copy for use in any prosecution in respect of the 
sample. 

(3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be 
evidence to the facts stated therein, and such evidence shall be conclusive unless the person from whom the 

5
sample  was  taken 
[or  the  person  whose  name,  address  and  other  particulars  have  been  disclosed  under 
section  18A]  has,  within  twenty-eight  days of  the  receipt  of  a  copy  of  the  report,  notified  in  writing  the 
Inspector  or  the  Court  before  which  any  proceedings  in respect of the sample are pending that he intends to 
adduce evidence in controversion of the report. 

(4)  Unless  the  sample  has  already  been  tested  or  analysed  in  the  Central  Drugs  Laboratory,  where  a 
person  has under sub-section (3) notified his intention of adducing evidence in controversion of a Government 
Analyst‘s report, the Court may, of its own motion or in its discretion at the request either of the complainant 

3
[or  cosmetic]  produced  before  the  Magistrate  under  sub-
or  the  accused,  cause  the  sample  of  the  drug 
section  (4)  of  section  23  to  be  sent  for  test  or analysis to the said Laboratory, which shall make the test or 
analysis  and  report  in  writing  signed  by,  or  under  the  authority  of,  the  Director  of  the  Central  Drugs 
Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein. 

(5)  The  cost  of  a  test  or  analysis  made  by  the  Central  Drugs  Laboratory  under  sub-section  (4)  shall  be 

paid by the complainant or accused as the Court shall direct. 

26.  Purchaser  of  drug  3[or  cosmetic]  enabled  to  obtain  test  or  analysis.—Any  person 

[or  any 
recognised  consumer  association,  whether  such  person  is  a  member  of  that  association  or  not,]  shall,  on 
application  in  the  prescribed  manner and on payment of the prescribed fee, be entitled to submit for test or 

6

3

7
[purchased by him or it] and to receive a report of 

analysis to a Government Analyst any drug 
such test or analysis signed by the Government Analyst. 

[or cosmetic] 

8

9

10

[Explanation.—For  the  purposes  of  this  section  and  section  32,  ―recognised  consumer  association‖  
means  a voluntary consumer association registered under the Companies Act, 1956 (1 of 1956) or any other 
law for the time being in force.] 

[26A. Power of Central Government to prohibit manufacture, etc., of drug and cosmetic in public 
interest.— Without prejudice to any other provision contained in this Chapter, if the Central Government is 
satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that 
any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients 
and  in  such  quantity  for  which  there  is  no  therapeutic  justification  and  that  in  the  public  interest  it  is 
necessary  or  expedient  so  to  do,  then,  that  Government  may,  by  notification  in  the  Official  Gazette, 
11[regulate, restrict or prohibit] the manufacture, sale or distribution of such drug or cosmetic.] 

12[26B. Powers of Central Government to regulate or restrict, manufacture, etc., of drug in public 
interest. – Without prejudice to any other provision contained in this Chapter, if the Central Government is 
satisfied that a drug is essential to meet the requirements of an emergency arising due to epidemic or natural 
calamities and that in the public interest it is necessary or expedient so to do, then, that Government may, by 
notification in the Official Gazette, regulate or restrict the manufacture, sale or distribution of such drug.] 

[27.  Penalty  for  manufacture,  sale,  etc.,  of  drugs  in  contravention  of  this  Chapter.—Whoever, 
himself  or by any other person on his  behalf,  manufactures  for  sale or for distribution, or  sells,  or  stocks or 
exhibits or offers for sale or distributes, — 
1.  Ins. by Act 35 of 1960, s. 6 (w.e.f. 16-3-1961).                                                              9.  Ins. by Act 68 of 1982, s. 21  (w.e.f. 1-2-1983). 
2.  Subs. by Act 68 of 1982, s. 20, for ―a Magistrate‖  (w.e.f. 1-2-1983).                            10. Subs. by Act 68 of 1982 s. 22, for s.  27 (w.e.f. 1-2-1983). 
3.  Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964).                                                            11. Sub. by Act 26 of 2008, s 4, for ―prohibit‖ (w.e.f 10-8-2009). 
4.  Subs. by Act 13 of 1964, s. 17, for certain words (w.e.f. 15-9-1964).                            12. Ins. by Act 26 of 2008, sec 5(w.e.f. 10-8-2009). 
5.  Subs. by Act 13 of 1964 s.17, for ―or the said warrantor‖(w.e.f. 15-9-1964). 
6.  Ins. by Act 71 of 1986, s. 2  (w.e.f. 15-9-1987). 
7.  Subs. by Act 71 of 1986 s. 2, for  ―purchased by him‖  (w.e.f. 15-9-1987). 
8.  Added by Act 71 of 1986 s. 2, (w.e.f. 15-9-1987). 

20 

 
 
Drugs and Cosmetics Act, 1940 

(a)  any  drug  deemed  to  be  adulterated  under  section  17A  or  spurious  under  section  1[17B  and 
which]  when  used  by  any  person  for  or  in  the  diagnosis,  treatment,  mitigation,  or  prevention  of  any 
disease  or  disorder  is  likely  to  cause  his  death  or  is  likely  to  cause  such  harm  on  his  body  as  would 
amount to grievous hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860), solely 
on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall 
be 2[punishable with imprisonment for a term which shall not be less than ten years but which may extend 
to a term of life and with fine which shall not be less than ten lakh rupees or three times value of the drugs 
confiscated, whichever is more;] 

3[Provided that the fine imposed on and released from, the person convicted under this clause shall be 
paid, by way of compensation, to the person who had used the adulterated or spurious drugs referred to in 
this clause. 

Provided further that where the use of the adulterated or spurious drugs referred to in this clause has 
caused  the  death  of  a  person  who  used  such  drugs,  the  fine  imposed  on  and  realised  from,  the  person 
convicted under this clause, shall be paid to the relative of the person who had died due to the use of the 
adulterated or spurious drugs referred to in this clause. 
Explanation.—For the purposes of the second proviso, the expression "relative" means— 
(i) spouse of the deceased person; or 
(ii) a minor legitimate son, and unmarried legitimate daughter and a widowed mother; or 
(iii) parent of the minor victim; or 
(iv) if wholly dependent on the earnings of the deceased person at the time of his death, a son or a daughter 
who has attained the age of eighteen years; or 
(v) any person, if wholly or in part, dependent on the earnings of the deceased person at the time of this 
death,— 
       (a) the parent; or 
       (b) a minor brother or an unmarried sister; or 
       (c) a widowed daughter-in-law; or 
       (d) a widowed sister; or 
       (e) a minor child of a pre-deceased son; or 
       (f) a minor child of a pre-deceased daughter where no parent of the child is alive; or 
       (g) the paternal grandparent if no parent of the member is alive.] 

           (b) any drug— 

(i) deemed to be adulterated under section 17A, but not being a drug referred to in clause (a), or 
(ii) without a valid licence as required under clause (c) of section 18, 

shall be punishable with imprisonment for a term  which shall 4[not be less than three year but which may 
extend to five years and with fine which shall not be less than one lakh rupees or three times the value of 
the drugs confiscated, whichever is more]: 

Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, 
impose a sentence of imprisonment for a term of 5[less than three years and of fine of less than one lakh 
rupees]; 

(c) any drug deemed to be spurious under section 17B, but not being a drug referred to in clause (a) 
shall be punishable with  imprisonment  for  a  term which shall  6[not be less  than  seven years  but  which 
may  extend  to  imprisonment  for  life  and  with  fine  which shall not be less than three lakh rupees or 
three times the value of the drugs confiscated, whichever is more]: 

Provided  that  the  Court  may,  for  any  adequate  and  special  reasons,  to  be  recorded  in  the 
judgment,  impose  a  sentence  of imprisonment for a term of 7[less than seven years but not less than three 
years and of fine of less than one lakh rupees]; 

(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention 
of  any  other  provision  of  this  Chapter  or  any  rule  made  thereunder,  shall  be  punishable  with 
imprisonment for  a term  which  shall  not be  less than  one year but which may extend to two years 8[and 
with fine which shall not be less than twenty thousand rupees]: 

Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment 

impose a sentence of imprisonment for a term of less than one year. 

1. Sub. by Act 26 of 2008, s 6(i)(A), for ―17B or which‖ (w.e.f 10-8-2009). 
2. Sub. by Act 26 of 2008, s 6(i)(B), for ―punishable with imprisonment for a term which shall not be less than five years but which may extend to a term 
of life and with fine which shall not be less than ten thousand rupees;‖ (w.e.f 10-8-2009). 
3. Ins. by Act 26 of 2008, s. 6(i)(C) (w.e.f.10-8-2009). 
4. Sub. by Act 26 of 2008, s 6(ii)(A), for ―not be less than one year but which may extend to three years and with fine which shall not be less than five 
thousand rupees;‖ (w.e.f 10-8-2009). 
5. Sub. by Act 26 of 2008, s 6(ii)(B),for ―less than one year and of fine of less than five thousand rupees;‖ (w.e.f 10-8-2009). 
6. Sub. by Act 26 of 2008, s 6(iii)(A),(w.e.f 10-8-2009). 
7. Sub. by Act 26 of 2008, s 6(iii)(B),(w.e.f 10-8-2009). 8. Sub. by Act 26 of 2008, s 6(iv), for ―and with fine‖ (w.e.f 10-8-2009).

21 

 
 
 
 
Drugs and Cosmetics Act, 1940 

8[27A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter.—Whoever 
himself or by any other person on his behalf manufactures for sale or for distribution, or sells, or stocks or 
exhibits or offers for sale— 

9[(i) any cosmetic deemed to be spurious under section 17D or adulterated under section 17E shall be 
punishable with imprisonment for a term which may extend to three years and with fine which shall not be 
less than fifty thousand rupees or three times to value of the cosmetics confiscated, whichever is more; 

(ii) any cosmetic other than a cosmetic referred to in clause (i) in contravention of any provisions of this 
Chapter or any rule made thereunder shall be punishable with imprisonment for a term which may extend 
to one year or with fine which may extend to twenty thousand rupees, or with both.] 

1[28.    Penalty  for  non-disclosure  of  the  name  of  the  manufacturer,  etc.—Whoever  contravenes  the 
provisions of section 18A 2[or section 24] shall be  punishable with imprisonment for a term which may 
extend to one year, or  3[with fine which shall not be less than twenty thousand rupees or with both.] 

4[28A.  Penalty  for  not  keeping  documents,  etc.,  and  for  non-disclosure  of  information.—Whoever 
without  reasonable  cause  or  excuse,  contravenes  the  provisions  of  section  18B  shall  be  punishable  with 
imprisonment  for  a  term  which  may  extend  to  one  year  or  12[with fine  which shall  not be less than  twenty 
thousand rupees or with both]. 

28B. Penalty for manufacture, etc., of drugs or cosmetics in contravention of section 26A.—Whoever 
himself  or  by  any  other  person  on  his  behalf  manufactures  or  sells  or  distributes  any  drug  or  cosmetic  in 
contravention  of  the  provisions  of  any  notification  issued  under  section  26A,  shall  be  punishable  with 
imprisonment for a term which may extend to three years and shall also be liable to fine which may extend to 
five thousand rupees.] 

29.  Penalty  for  use  of  Government  Analyst‘s  report for  advertising.—Whoever  uses  any  report  of a 
test  or  analysis  made  by  the  Central  Drugs  Laboratory  or  by  a  Government  Analyst,  or  any  extract  from 
such report, for the purpose of advertising any drug 5[or cosmetic], shall be punishable with fine, which may 
extend to five hundred rupees. 

6[30.  Penalty for subsequent offences.— 7[(1) Whoever having been convicted of an offence— 

(a)  Under  clause  (b)  of  section  27,  is  again  convicted  of  an  offence  under  that  clause,  shall  be 
punishable with imprisonment  for  a  term  which  shall  not  be  1 0[less  than  seven  years  but  which  may 
extend to  ten years and with fine which shall not be less than two lakh rupees]; 

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, 
impose a sentence of imprisonment for a term of 11[less than seven years and of fine of less than one lakh 
rupees]; 

1.  Subs. by Act 13 of 1964, s.19, for s. 28 (w.e.f.15-9-1964). 
2.  Ins. by Act 68 of 1982, s. 23 (w.e.f. 1-2-1983). 
3.  Subs. by Act 26 of 2008 s. 7. Earlier Subs. by Act 68 of 1982, s.23. 
4.  Ins. by Act 68 of 1982, s. 24,  (w.e.f. 1-2-1983). 
5.  Ins. by Act 21 of 1962, s. 15 (w.e.f.27-7-1964). 
6.  Subs. by Act 11 of 1955, s. 14, for s. 30. 
7.  Subs. by Act 68 of 1982, s. 25, for sub-section (1) (w.e.f. 1-2-1983). 
8. Subs. by Act 68 of 1982 s. 22, for s.  27A (w.e.f. 1-2-1983), Earlier s. 27A was inserted by Act 21 of 1962, s 19 (w.e.f. 27-7-1964). 
9. Subs. by Act 26 of 2008 s. 7, for clause (i) and (ii) (w.e.f. 10-8-2009). 

10.  Subs. by Act 26 of 2008 sec. 11(a)(i)(A), for ―less than two years but which may extend to six years and with fine which shall not be less than ten 

thousand rupees‖;( w.e.f. 10-8-2009)  

11. Subs. by Act 26 of 2008 sec. 11(a)(i)(B), for ―less than two years and of fine of less than ten thousand rupees‖; (w.e.f. 10-8-2009). 
12. Subs. by Act 26 of 2008 s. 7, for ―with fine which may extend to one thousand rupees or with both‖ (w.e.f. 10-8-2009).

22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(b)  under  clause  (c)  of  section  27  is  again  convicted  of  an  offence  under  that  clause,  shall  be 
punishable with imprisonment  for  a  term  which  shall  1 2 [ less  than  ten  years  but  which  may  extend  to 
imprisonment for life and with fine which shall not be less than three lakh rupees]; 

(c)  under  clause  (d)  of  section  27,  is  again  convicted  of  an  offence  under  that  clause  shall  be 
punishable with imprisonment  for  a  term  which  shall  not  be  less  than  two  years  but  which  may  extend 
to  four years or with  fine which shall not be less than 13[fifty thousand rupees], or with both.] 

1[(1A)  Whoever,  having  been  convicted  of  an  offence  under  section  27A  is  again  convicted  under  that 
section, shall be punishable with imprisonment for a term which may extend to two years, or with fine which 
may extend to 2[two thousand rupees], or with both.] 

(2)  Whoever,  having  been  convicted  of  an  offence  under  3[*  *  *]  section  29  is  again  convicted  of  an 
offence  under  the  same  section  shall  be  punishable  with  imprisonment  which  may  extend  to  4[two  tears,  or 
with fine which shall not be less than ten thousand rupees], or with both.] 

5
[(1)] Where any person has been convicted under this Chapter for contravening any 
such provision of this Chapter or any rule made thereunder as may be specified by rule made in this behalf, the 

31. Confiscation.—

stock  of  the  drug 

[or  cosmetic]  in  respect  of  which  the  contravention  has  been  made  shall  be  liable  to 

6

confiscation 

7
[and if such contravention is in respect of— 

8

[(i)  manufacture  of  any  drug  deemed  to  be  misbranded  under  section  17,  adulterated  under  section 

17A or spurious under section 17B; or 

9
[manufacture for sale, or for distribution, sale, or stocking or exhibiting or offering for sale,] or 

(ii) 

distribution of any drug without a valid licence as required under clause (c) of section 18; 

any implements or machinery used in such manufacture, sale or distribution and any receptacles, packages or 
coverings  in  which  such  drug  is  contained  and  the  animals,  vehicles,  vessels  or  other  conveyances  used  in 
carrying such drug shall also be liable to confiscation.] 

10

[(2) Without prejudice to the provisions contained in sub-section (1) where the Court is satisfied, on the 
application  of  an  Inspector  or  otherwise  and  after  such  inquiry  as  may  be  necessary  that  the  drug  or 

cosmetic  is  not  of  standard  quality  or  is  a 
spurious cosmetic,] such drug or, as the case may be, such cosmetic shall be liable to confiscation.] 

[misbranded,  adulterated  or  spurious  drug  or  misbranded  or 

9

11

[31A. Application of provisions to Government departments.—The provisions of this Chapter except 
those contained in  section 31 shall apply in relation  to  the  manufacture, sale or distribution  of drugs of any 
department  of Government as they apply in relation to the manufacture, sale or distribution of drugs by any 
other person.] 

32. Cognizance of offence.—14[(1) No prosecution under this Chapter shall be instituted except by- 

1.    Ins. by Act 21 of 1962, s. 20 (w.e.f. 27-7-1964). 
2.    Subs. by Act 68 of 1982, s. 25, for ―one thousand rupees‖ (w.e.f. 1-2-1983). 
3.    The words and figures ―section 28 or‖ omitted by Act 13 of 1964, s. 26 (w.e.f. 15-9-1964). 
4.    Subs. by Act 26 of 2008 sec. 11(b), for ―ten years, or with fine, or with both‖. 
5.    S. 31 re-numbered as sub-section (1) by Act 35 of 1960, s. 9  (w.e.f. 16-3-1961). 
6.    Ins. by Act 21 of 1962, s. 21 (w.e.f. 27-7-1964). 
7.    Ins. by Act 13 of 1964, s. 21 (w.e.f. 15-9-1964). 
8.    Subs. by Act 68 of 1982, s. 26, for cl. (i) (w.e.f. 1-2-1983). 
9.    Subs. by s. 26, ibid., for certain words (w.e.f. 1-2-1983). 
10.  Sub-section  (2) ins. by Act 35 of 1960, s. 9 and subs. by Act 21 of 1962, s. 21 (w.e.f. 27-7-1964). 
11.  Ins. by Act 13 of 1964, s. 22 (w.e.f.15-9-1964). 
12. Subs. by Act 26 of 2008 sec. 11(a)(ii), for ―less than six years but which may extend to ten years and with fine which shall not be less than ten 

thousand rupees ‖;( w.e.f. 10-8-2009)  

13. Subs. by Act 26 of 2008 sec. 11(a)(iii), for ―five thousand rupees ‖; (w.e.f. 10-8-2009) 
14. Subs. by Act 26 of 2008, sec 12, for sub-section (1) and (2) (w.e.f. 10-8-2009)

23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(a)  an Inspector, or  
(b)  any gazetted Officer of the Central Government or a State Government authorized in writing in this 
behalf by the Central Government or a State Government by a general or special order made in this 
behalf by that Government; or  

(c)  the person aggrieved; or  
(d)  a recognised consumer association whether such person is a member of that association or not. 

(2) Save as otherwise provided in this Act, no court inferior to that of a Court of Sessions shall try an 
offence punishable under this Chapter.] 

(3) Nothing contained in this Chapter shall be deemed to prevent any person from being prosecuted under 

any other law for any act or omission which constitutes an offence against this Chapter. 

1

[32A.   Power of Court to implead the manufacturer, etc.—Where, at any time during the trial of any 
offence under  this  Chapter  alleged  to  have  been  committed  by  any  person,  not being  the  manufacturer  of  a 
drug  or  cosmetic  or  his  agent  for  the  distribution  thereof,  the  Court  is  satisfied,  on  the  evidence  adduced 
before  it,  that  such  manufacturer  or  agent  is  also  concerned  in  that  offence,  then,  the  Court  may, 

notwithstanding anything contained 
[in sub-sections (1), (2) and (3) of section 319  of the Code of Criminal 
Procedure,1973  (2  of  1974)]  proceed  against  him  as  though  a  prosecution  had  been  instituted  against  him 
under section 32.] 

2

3[32B.  Compounding  of  certain  offences.-  (1)  Notwithstanding  anything  contained  in  the  Code  of 
Criminal Procedure, 1973 (2 of 1974), any offence punishable under clause (b) of sub-section (1) of Section 
13, Section 28 and Section 28A of this Act(whether committed by a company or any officer thereof), not being 
an offence punishable with imprisonment only, or with imprisonment and also with fine, may, either before or 
after  the  instructions  of  any  prosecution,  be  compounded  by  the  Central  Government  or  by  any  State 
Government or any officer authorized in this behalf Central Government or a State Government, on payment 
for credit to that Government of such sum as that Government may, by rules made in this behalf, specify:  

Provided  that  such  sum  shall  not,  in  any  case,  exceed  the  maximum  amount  of  the  fine  which  may  be 

imposed under this Act for the offences so compounded:  

Provided further that in cases of subsequent offences, the same shall not be compoundable.  

(2)  When  the  accused  has  been  committed  for  trial  or  when  he  has  been  convicted  and  an  appeal  is 
pending,  no  composition  for  the  offences  shall  be  allowed  without  the  leave  of  the  court  to  which  he  is 
committed or, as the case may be, before which the appeal is to be heard.  

(3)  Where  an  offence  is  compounded  under  sub-section  (1),  no  proccding  or  further  proceeding,  as  the 
case may be , shall be taken against the offender in respect of the offences so compounded and the offender, if 
in custody, shall be released forthwith.] 

33.    Power  of  Central  Government  to  make  rules.—

5
[after 
consultation  with, or on the recommendation of, the Board] and after previous publication by notification in 
the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter: 

[(1)  The  Central  Government  may 

4

Provided that consultation with the Board may be dispensed with if the Central Government is of opinion 
that circumstances  have  arisen  which  render  it  necessary  to  make  rules  without  such  consultation,  but  in 
such  a  case  the  Board  shall  be  consulted  within  six  months  of  the  making  of  the  rules  and  the  Central 
Government  shall  take  into  consideration  any  suggestions  which  the  Board  may  make  in  relation  to  the 
amendment of the said rules.] 

1.  Ins. by Act 13 of 1964, s. 23  (w.e.f.15-9-1964). 
2.  Subs. by Act 68 of 1982, s. 28, for certain words (w.e.f. 1-2-1983). 
3.  Ins. by Act 26 of 2008, s. 13; (w.e.f. 10-8-2009) 
4.  Subs. by Act 11 of 1955, s. 15, for sub-section (1). 
5.  Subs. by Act 68 of 1982, s. 29, for certain words (w.e.f. 1-2-1983). 

24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

 (2) Without prejudice to the generality of the foregoing power, such rules may— 

(a) provide for the establishment of laboratories for testing and analysing drugs 

1
[or cosmetics]; 

(b) prescribed the qualifications and duties of Government Analysts and the qualifications of  
Inspectors; 

(c) prescribe the methods of test or analysis to be employed in determining whether a drug 

1

[or 

cosmetic] is of standard quality; 

(d) prescribe, in respect of biological and organometallic compounds, the units or methods of 
standardisation; 

2
[(dd) prescribe under clause (d) of 

3

contain for purposes of colouring;] 

[section 17A] the colour or colours which a drug may bear or 

4[(dda) prescribe under clause (d) of section 17E the colour or colours which a cosmetic may bear or 

contain for purposes of colouring]; 

(e) prescribe the forms of licences 

6
[for the manufacture for sale or for distribution], for the sale 
[or  of  cosmetics  or  any 
and  for  the  distribution  of  drugs  or  any  specified  drug  or  class  of  drugs 
specified  cosmetic  or  class  of  cosmetics],  the  form  of  application  for  such  licences,  the  conditions 
[,  the 
subject  to  which  such  licences  may  be  issued,  the  authority  empowered  to  issue  the  same 

1

3

qualification  of  such  authority]  and  the  fees  payable  therefor 
[and  provide  for  the  cancellation  or 
suspension  of  such  licences  in  any  case  where  any  provision  of  this  Chapter  or  the  rules  made 
thereunder  is contravened  or  any  of  the  conditions subject to  which  they  are  issued  is  not  complied 
with;] 

3

3

[(ee)  prescribe  the  records,  registers  or  other  documents  to  be  kept  and  maintained  under 
section 18B; 

(eea)  prescribe  the  fees  for  the  inspection  (for  the  purposes  of  grant  or  renewal  of  licence)  of 

premises, wherein any drug or cosmetic is being or is proposed to be manufactured; 

(eeb)    prescribe  the  manner  in  which  copies  are  to  be  certified  under  sub-section  (2A)  of 
section 22;] 

(f) specify the diseases or ailments which a drug may not purport or claim 
mitigate] 

and such other effects which a drug may not purport or claim to have; 

5

[to prevent, cure or 

(g)  prescribe  the  conditions  subject  to  which  small  quantities  of  drugs  may  be 

manufactured  for  the purpose of examination, test or analysis; 

1.  Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964). 
2.  Ins. by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964). 
3.  Ins. by Act 68 of 1982, s. 29 ( w.e.f. 1-2-1983). 
4.  Ins. by Act 26 of 2008, s. 14(i) (w.e.f. 10-8-2009) 
5.  Subs. by Act 11 of 1955, s. 15, for ―to cure or mitigate‖. 
6. Subs. By Act 68 of 1982, s. 29 ( w.e.f. 1-2-1983).

25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(h) require the date of manufacture and the date of expiry of potency to be clearly or truly stated 
on the label or container of any specified drug or class of drugs, and prohibit the sale, stocking or 
exhibition for sale, or distribution of the said drug or class of drugs after the expiry of a specified 
period from the date of manufacture or after the expiry of the date of potency; 

(i)  prescribe  the  conditions  to  be  observed  in  the  packing  in  bottles,  packages,  and  other 
2
1
containers of drugs 
[including the use of packing material which comes into direct 
contact with the drugs] and prohibit the sale, stocking or exhibition for sale, or distribution of drugs 
1
[or cosmetics] packed in contravention of such conditions; 

[or cosmetics], 

(j) regulate the mode of labelling packed drugs 1[or cosmetics], and prescribe the matter which 

shall or shall not be included in such labels; 

(k)  prescribe  the  maximum  proportion  of  any  poisonous  substance  which  may  be  added  or 
contained  in  any  drug,  prohibit  the  manufacture,  sale  or  stocking  or  exhibition  for  sale,  or 
distribution of any drug in which that proportion is exceeded, and specify substances which shall be 
deemed to be poisonous for the purposes of this Chapter and the rules made thereunder; 

(l)  require  that  the  accepted  scientific  name  of  any  specified  drug  shall  be  displayed  in  the 
prescribed  manner  on  the  label  or  wrapper  of  any  patent  or  proprietary  medicine  containing  such 
drug; 
3

[****] 
4
[(n)  prescribe  the  powers  and  duties  of  Inspectors 

5
[and  the  qualifications  of  the  authority  to 
6
which such Inspectors shall be subordinate] and 
[specify the drugs or classes of drugs or cosmetics 
or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to 
which, such powers and duties may be exercised or performed;] 

(o)  prescribe  the  forms  of  report  to  be  given  by  Government  Analysts,  and   the  manner  of 

application for test  or analysis under section 26 and the fees payable therefor; 

[(p)  specify  the  offences  against  this  Chapter  or  any  rule  made  thereunder  in  relation  to 

which  an  order  of confiscation may be made under section 31; 8[****]] 
(q) provide for the exemption, conditionally or otherwise, from all or any of the provisions of 
this  Chapter  or  the rules made thereunder, of any specified drug or class of drugs 1[or cosmetic or 
class of cosmetics]; 9[and] 

10[(r) sum which may be specified by the Central Government under section 32-B.] 
11[****] 

7

12[33A.  Chapter  not  to  apply  to      13[Ayurvedic,  Siddha  or  Unani]  drugs.—Save  as  otherwise 

provided in this Act, nothing contained in this Chapter shall apply to 13[Ayurvedic, Siddha or Unani] drugs.] 

PROVISIONS RELATING TO 

13

[AYURVEDIC, SIDDHA AND UNANI] DRUGS 

14

[CHAPTER IVA 

33B. Application of Chapter IVA.—This Chapter shall apply only to 

13

[Ayurvedic, Siddha and Unani] 

drugs. 

15

33C. 

[Ayurvedic,  Siddha  and  Unani    Drugs  Technical  Advisory  Board].—(1)  The  Central 
Government shall, by notification in the Official Gazette and with effect from such date as may be specified 
therein,  constitute  a  Board  (to  be  called  the 
[Ayurvedic,  Siddha  and  Unani  Drugs  Technical  Advisory 
Board])  to  advise  the  Central  Government  and  the  State  Governments  on  technical matters arising out of 
this Chapter and to carry out the other functions assigned to it by this Chapter. 

15

(2) The Board shall consist of the following members, namely:— 

1.    Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964). 
2.    Ins. by Act 68 of 1982, s. 29 (w.e.f. 1-2-1983). 
3.    Cl. (m) omitted by Act 13 of 1964, s. 24 (w.e.f. 15-9-1965). 
4.    Subs. by Act 35 of 1960, s. 10, for cl. (n) (w.e.f. 16-3-1961). 
5.    Ins. by Act 68 of 1982, s. 29 (w.e.f. 15-9-1965). 
6.    Subs. by Act 21 of 1962, s. 22, for ―the drugs or class of drugs‖ (w.e.f. 27-7-1964). 
7.    Subs. by Act 13 of 1964, s. 24, for cl. (p) (w.e.f. 15-9-1964). 
8.   The word ―and‖omitted by Act 26 of 2008, sec. 14(ii) (w.e.f. 10-8-2009) 
9.   Ins. by Act 26 of 2008, Sec. 14 (iii) (w.e.f. 10-8-2009) 
10. Ins. by Act 26 of 2008, Sec. 14 (iv) (w.e.f. 10-8-2009) 
11.    Sub-section (3) ins. by Act 35 of 1960 and omitted by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964). 
12.   Ins. by Act 13 of 1964, s. 25 (w.e.f. 1-2-1969). 
13.   Subs. by Act 68 of 1982, s. 2, for ―AYURVEDIC (INCLUDING SIDDHA) OR UNANI‖  (w.e.f. 1-2-1983). 
14.   Ins. by Act 13 of 1964, s. 26  (w.e.f. 1-2-1969). 
15.   Subs. by Act 68 of 1982, s. 30, for certain words (w.e.f. 1-2-1983).

26 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(i) the Director General of Health Services, ex officio; 

(ii) the Drugs Controller, India, ex officio; 

1[(iii)  the principal officer dealing with Indian systems of medicine in the Ministry of  Health, ex officio;] 

(iv) the Director of the Central Drugs Laboratory, Calcutta, ex officio; 

(v)  one  person  holding  the  appointment  of  Government  Analyst  under  section  33F,  to  be  nominated  by  the 

Central Government; 

(vi)  one Pharmacognocist to be nominated by the Central Government; 

(vii) one Phyto-chemist to be nominated by the Central Government; 

2[(viii)    four  persons  to  be  nominated  by  the  Central  Government,  two  from  amongst  the  members  of  the 
Ayurvedic Pharmacopoeia Committee, one from amongst the members of the Unani Pharmacopoeia Committee and 
one from amongst the members of the Siddha Pharmacopoeia Committee;] 

(ix) one teacher in Dravyaguna and Bhaishajya Kalpana, to be nominated by the Central Government; 

(x)   one   teacher   in   ILM-UL-ADVIA   and   TAKLIS-WA-DAWA-SAZI,   to   be   nominated   by   the   Central 

Government; 

3[(xi) one teacher in Gunapadam, to be nominated by the Central Government; 

(xii) three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the 

Central Government; 

(xiii)  three  persons,  one  each  from  among  the  practitioners  of  Ayurvedic,  Siddha  and  Unani  Tibb  system  of 

medicine, to be nominated by the Central Government.] 

(3) The Central Government shall appoint a member of the Board as its Chairman. 

(4) The nominated members of the Board shall hold office for three years but shall be eligible for renomination. 

(5) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and 

regulating its own procedure and conduct of all business to be transacted by it. 

(6) The functions of the Board may be exercised notwithstanding any vacancy therein. 

(7) The  Central Government  shall appoint a person  to be  Secretary of  the Board and shall provide the Board  with 

such clerical and other staff as the Central Government considers necessary. 

4[33D.  The  Ayurvedic,  Siddha  and  Unani  Drugs  Consultative  Committee.—(1)  The  Central  Government  may 
constitute an Advisory Committee to be called the Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise 
the Central Government, the State Governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board 
on  any  matter  for  the  purpose  of  securing  uniformity  throughout  India  in  the  administration  of  this  Act  in  so  far  as  it 
relates to Ayurvedic, Siddha or Unani drugs. 

(2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two persons to be nominated 
by the Central Government as representatives of that Government and not more than one representative of each State to 
be nominated by the State Government concerned. 

(3)  The  Ayurvedic,  Siddha  and  Unani  Drugs  Consultative  Committee  shall  meet  when  required  to  do  so  by  the 

Central Government and shall regulate its own procedure. 

33E. Misbranded drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drugs shall be deemed 

to be misbranded— 

1. Subs. by Act 68 of 1982, s. 30, for cl. (iii)  (w.e.f. 1-2-1983). 
2. Subs. by Act 68 of 1982, s. 30, for cl. (viii)  (w.e.f. 1-2-1983). 
3. Subs. by Act 68 of 1982, s. 30, for cls.  (xi) and (xii) (w.e.f. 1-2-1983). 
4. Subs. by Act 68 of 1982, s. 31, for ss. 33D and 33E (w.e.f. 1-2-1983).

27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(a) if it is so coloured, coated, powered or polished that damage is concealed, or if it is made to appear of better 

or greater therapeutic value than it really is; or 

(b) if it is not labelled in the prescribed manner; or 

(c)  if  its  label  or  container  or  anything  accompanying  the  drug  bears  any  statement,  design  or  device  which 

makes any false claim for the drug or which is false or misleading in any particular. 

33EE. Adulterated drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed 

to be adulterated,— 

(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or 

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated 

with filth or whereby it may have been rendered injurious to health; or 

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render 

the contents injurious to health; or 

(d) if it bears or contains, for purposes of coloring only, a colour other than one   which is prescribed; or 

(e) if it contains any harmful or toxic substance which may render it injurious to  health; or 

(f) if any substance has been mixed therewith so as to reduce its quality or strength. 

Explanation.—For  the  purpose  of  clause  (a),  a  drug  shall  not  be  deemed  to  consist,  in  whole  or  in  part,  of  any 
decomposed  substance  only  by  reason  of  the  fact  that  such  decomposed  substance  is  the  result  of  any  natural 
decomposition of the drug: 

Provided  that  such  decomposition  is  not  due  to  any  negligence  on  the  part  of  the  manufacturer  of  the  drug  or  the 

dealer thereof and that it does not render the drug injurious to health. 

33EEA. Spurious drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed 

to be spurious— 

(a) if it is sold, or offered or exhibited for sale, under a name which belongs to another drug; or 

(b) if it is an  imitation  of, or is a substitute for, another drug  or resembles another  drug  in  a  manner likely to 
deceive,  or  bears  upon  it  or  upon  its  label  or  container  the  name  of  another  drug,  unless  it  is  plainly  and 
conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or 

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the 

drug, which individual or company is fictitious or does not exist; or 

(d) if it has been substituted wholly or in part by any other drug or substance; or 

(e) if it purports to be the product of  a manufacturer of whom it is not truly a  product. 

33EEB.  Regulation  of  manufacture  for  sale  of  Ayurvedic,  Siddha  and  Unani  drugs.—No  person  shall 
manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordance with such standards, 
if any, as may be prescribed in relation to that drug. 

33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drug.—From such date 
as the State Government may, by notification in the Official Gazette, specify in this behalf, no person, either by himself 
or by any other person on his behalf, shall— 

(a) manufacture for sale or for distribution— 

(i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drugs; 

(ii)  any  patent  or  proprietary  medicine,  unless  there  is  displayed  in  the  prescribed  manner  on  the  label  or 

container thereof the true list of all the ingredients contained in it; and

28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(iii) any Ayurvedic, Siddha or Unani drug in contravention of any of the provisions of this Chapter or any 

rule made thereunder; 

(b)  sell,  stock  or  exhibit or offer  for  sale  or  distribute,  any  Ayurvedic,  Siddha or  Unani  drug  which  has  been 

manufactured in contravention of any of the provisions of this Act, or any rule made thereunder; 

(c)  manufacture  for  sale  or  for  distribution,  any  Ayurvedic,  Siddha  or  Unani  drug,  except  under,  and  in 

accordance with the conditions of, a licence issued for such purpose under this Chapter by the prescribed authority: 

Provided  that  nothing  in  this  section  apply  to  Vaidyas  and  Hakims  who  manufacture  Ayurvedic,  Siddha  or  Unani 

drug for the use of their own patients: 

Provided further that nothing in this section shall apply to the manufacture, subject to the prescribed conditions, of 

small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination, test or analysis. 

33EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in 
public  interest.—Without  prejudice  to  any  other  provision  contained  in  this  Chapter,  if  the  Central  Government  is 
satisfied on the basis of any evidence or other material available before it that the use of any Ayruvedic, Siddha or Unani 
drug is likely to involve any risk to human beings or animals or that any such drug does not have the therapeutic value 
claimed or purported to be claimed for it and   that in the public interest it is   necessary or expedient so to do then, that 
Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug.] 

33F.  Government  Analysts.—(1)  The  Central  Government  or  a  State  Government  may,  by  notification  in  the 
Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for 
such areas as may be assigned to them by the Central Government or the State Government, as the case may be. 

(2) Notwithstanding anything contained in sub-section (1), neither the Central Government nor a State Government 
shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government 
under which he is serving. 

1[(3)  No  person  who  has  any  financial  interest  in  the  manufacture  or  sale  of  any  drug  shall  be  appointed  to  be  a 

Government Analyst under this section.] 

33G. Inspectors.—(1) The Central Government or a State Government may, by notification in the Official Gazette, 
appoint  such  persons  as  it  thinks  fit,  having  the  prescribed  qualifications,  to  be  Inspectors  for  such  areas  as  may  be 
assigned to them by the Central Government or the State Government, as the case may be. 

(2)  The  powers  which  may  be  exercised  by  an  Inspector  and  the  duties  which  may  be  performed  by  him  and  the 
conditions, limitations  or restrictions  subject to  which such  powers and  duties  may be  exercised  or performed  shall  be 
such as may be prescribed. 

(3)  No  person  who  has  any  financial  interest  in  the  manufacture  or  sale  of  any  drug  shall  be  appointed  to  be  an 

Inspector under this section. 

(4) Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code 
(45 of 1860) and shall be officially subordinate to such authority as the Government appointing him may specify in this 
behalf. 

33H. Application of provisions of sections 22, 23, 24 and 25.—The provisions of sections 22, 23, 24 and 25 and 
the rules, if any,  made thereunder shall,  so  far as  may  be,  apply  in  relation  to  an  Inspector  and  a  Government  Analyst 
appointed  under  this  Chapter  as  they  apply  in  relation  to  an  Inspector  and  a  Government  Analyst  appointed  under 
Chapter IV, subject to the modification that the references to ―drug‖ in the said section, shall be construed as references 
to 2[―Ayurvedic, Siddha or Unani] drugs‖. 

3[33-I.  Penalty  for  manufacture,  sale,  etc.,  of  Ayurvedic,  Siddha  or  Unani  drug  in  contravention  of  this 

Chapter —Whoever himself or by any other person on his behalf— 

(1) manufactures for sale or for distribution,— 

1.  Ins. by Act 68 of 1982, s. 32 (w.e.f.1-2-1983). 
2.  Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
3.  Subs. by Act 68 of 1982, s. 33, for ss. 33-I and 33J  (w.e.f.1-2-1983).

29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1[(a) Any Ayurvedic, Siddha or Unani drug –  

(i)  deemed to be misbranded under section 33E, 
(ii) deemed to be adulterated under section 33EE, or  
(ii) without a valid licence as required under clause (c) of section 33EEC,  

shall be punishable with imprisonment for a term which may extend to one year and with fine which shall not be less 
than twenty thousand rupees or three times the value of the drugs confiscated, whichever is more;] 

(b)  any  Ayurvedic,  Siddha  or  Unani  drug  deemed  to  be  spurious  under  section  33EEA,  shall  be  punishable 
with imprisonment for a term which shall not be less than one  year but which  may extend to three  years  and  with 
fine which shall not be less than 2[fifty thousand rupees or three times the value of the drugs confiscated, whichever 
is more]: 

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a 
sentence of  imprisonment for a  term of  less  than one  year  and of fine  of  less  than  2[fifty thousand rupees or three 
times the value of the drugs confiscated, whichever is more]; or 

3[(c) any Ayurvedic, Siddha or Unani drug in contravention of the provisions of any notifications issuedunder 
Section  33-EED  shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to  three  years  and  with  fine 
which may extend to fifty thousand rupees or three times the value of the drugs confiscated, whichever is more.] 

(2) contravenes any other provisions of this Chapter or of section 24 as applied by section 33H or any rule made 
under  this  Chapter,  shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to  4[ six months and with 
fine which shall not be less than ten thousand rupees.] 

5[33J. Penalty for subsequent offences.—Whoever  having being convicted of an offence,— 

(a) under clause (a) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall 
be punishable  with imprisonment  for a term  which  may extend to  two  years and  with  fine  which  shall  not be less 
than 6[fifty thousand rupees or three times the value of the drugs confiscated, whichever is more]; 

(b) under clause (b) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall 
be punishable with imprisonment for a term which shall not be less than two years but which may extend to six years 
and  with  fine  which  shall  not  be  less  than  7[one  lakh  rupees  or  three  times  the  value  of  the  drugs  confiscated, 
whichever is more:] 

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a 
sentence of imprisonment for a term of less than two years and of fine of less than 7[one lakh rupees or three times 
the value of the drugs confiscated, whichever is more;] 

1. Sub. by s. 15(a)(i), for clause (a) (w.e.f. 10.08.2008). Clause (a), before substitution, stood as:―(a) Any Ayurvedic, Siddha or Unani drug –  (i) deemed 
to be adulterated under section 33EE, or (ii) without a valid licence as required under clause (c) of section 33EEC, shall be punishable with imprisonment 
for a term which may extend to one year and with fine which shall not be less than two thousand rupees;‖ 
2. Sub. by Act 26 of 2008, s. 15(a)(ii), for ―five thousand rupees‖ (w.e.f. 10.08.2008) 
3. Ins. by Act 26 of 2008, s. 15(a)(iii)  (w.e.f. 10.08.2008)  
4. Sub. by Act 26 of 2008, s. 15(b) for ―three months and with fine which shall not be less than five hundred rupees.‖ (w.e.f. 10.08.2008) 
5. Sub by Act 68 of 1982,s.33 for section 33J(w.e.f. 01.02.1983) 
6. Sub. by Act 26 of 2008, s. 16(a), for ―two thousand rupees‖ (w.e.f. 10.08.2008) 
7. Sub. by Act 26 of 2008, s. 16(b), for ―five thousand rupees‖ (w.e.f. 10.08.2008) 

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(c)  under  sub-section  (2)  of  section  33-I  is  again  convicted  of  an  offence  under  that  sub-section, 
shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to  5[one year  and  with  fine  which 
shall not be less than twenty thousand rupees or three times the value of the drugs confiscated, whichever 
is more;] 

33K.  Confiscation.—Where  any  person  has  been  convicted  under  this  Chapter,  the  stock  of  the 
1[Ayurvedic, Siddha or Unani] drug, in respect of which the contravention has been made, shall be liable to 
confiscation. 

6[33-KA.  Disclosure of  name  of  manufacturer  etc.,  –Every  person,  not  being  the  manufacturer  of  any 
Ayurvedic, Siddha or Unani drug or his agent for the distribution thereof, shall, if so required, disclose to the 
Inspector the name, address and other particulars of the person from whom he acquired the Ayurvedic, Siddha 
or Unani drug.] 

6[33-KB. Maintenance of records and furnishing of information.— Every person holding a licence under 
clause (c) of section 33-EEC shall keep and maintain such records, registers and other documents as may be 
prescribed and shall furnish to any officer or authority exercising any power or discharging any function under 
this Act such information as is required by such officer or authority for carrying out the purposes of this Act. ] 

33L. Application of provisions to Government departments.—The provisions of this Chapter except 
those contained  in  section  33K  shall  apply  in  relation  to  the  manufacture  for  sale,  sale  or  distribution  of 

1
[Ayurvedic,  Siddha  or  Unani]  drug  by  any  department  of  Government  as  they  apply  in  relation  to  the 

any 
manufacture for sale, sale or distribution of such drug by any other person. 

33M. Cognizance of offences.—(1) No prosecution under this Chapter shall be instituted except by an 

Inspector 2[with the previous sanction of the authority specified under sub-section (4) of section 33G]. 

(2) No Court inferior to that 

3

[of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] 

shall try an offence punishable under this Chapter. 

[after 
33N.  Power  of  Central  Government  to  make  rules.—(1)  The  Central  Government  may, 
consultation with, or on the recommendation of, the Board] and after previous publication by notification in 
the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter: 

4

Provided  that  consultation  with  the  Board  may  be  dispensed  with  if  the  Central  Government  is  of 
opinion  that  circumstances have arisen which render it necessary to make rules without such consultation, but 
in  such  a  case,  the  Board  shall  be  consulted  within  six  months  of  the  making  of  the  rules  and  the  Central 
Government  shall  take  into  consideration  any  suggestions  which  the  Board  may  make  in  relation  to  the 
amendment of the said rules. 

(2) Without prejudice to the generality of the foregoing power, such rules may— 

(a) provide for the establishment of laboratories for testing and analysing 1[Ayurvedic, Siddha or 

Unani] drugs; 

1.  Subs. by Act 68 of 1982, s. 2, for ―Ayurvedic (including Siddha) and Unani‖  (w.e.f. 1-2-1983). 
2.  Ins. by Act 68 of 1982, s. 34,  (w.e.f. 1-2-1983). 
3.  Subs. by Act 68 of 1982, s. 34, for certain words (w.e.f. 1-2-1983). 
4.  Subs. by Act 68 of 1982 , s. 35, for certain words (w.e.f. 1-2-1983). 
5.  Sub. by Act 26 of 2008, s. 16(c), for ―six months and with fine which shall not be less than one thousand rupees.‖ (w.e.f. 10.08.2008) 
6.  Ins. by Act 26 of 2008, s. 17, (w.e.f. 10.08.2008).

31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(b) prescribe the qualification and duties of Government Analysts and the qualifications of Inspectors; 

(c) prescribe the methods of test or analysis to be employed in determining whether any 1[Ayurvedic, Siddha or 

Unani] drug is labelled with the true list of the ingredients which it is purported to contain; 

(d) specify any substance as a poisonous substance; 

(e) prescribe the forms of licences for the manufacture for sale of  1[Ayurvedic, Siddha or Unani] drugs,2[and for 
sale  of  processed  Ayurvedic,  Siddha  or  Unani  drugs,]  the  form  of  application  for  such  licences,  the  conditions 
subject  to  which  such  licences  may  be  issued,  the  authority  empowered  to  issue  the  same  and  the  fees  payable 
therefor;  2[and provide  for  the  cancellation or suspension  of such  licences in  any case  where any provision  of this 
Chapter  or  rules  made  thereunder  is  contravened  or  any  of  the  conditions  subject  to  which  they  are  issued  is  not 
complied with]; 

3[(f) prescribe the conditions to be observed in the packing of Ayurvedic, Siddha and Unani drugs including the 
use of packing material which comes into direct contact with the drugs, regulate the mode of labelling packed drugs 
and prescribe the matters which shall or shall not be included in such labels;] 

(g) prescribe  the  conditions  subject  to  which  small  quantities  of  1[Ayurvedic,  Siddha  or  Unani]  drugs  may  be 

manufactured for the purpose of examination, test or analysis; 

2[(gg) prescribe  under  clause  (d)  of  section  33EE  the  colour  or  colours  which  an  Ayurvedic,  Siddha  or  Unani 

drug may bear or contain for purposes of colouring; 

(gga) prescribe the standards for Ayurvedic, Siddha or Unani drugs under    section 33EEB 7[***];] 

8[(ggb) prescribe the records, registers or other documents to be kept and maintained under section 33 KB; and] 

(h) any other matter which is to be or may be prescribed under this Chapter. 

33-O.  Power  to  amend  First  Schedule.—The  Central  Government,  after  consultation  with  the  Board  and  after 
giving, by notification in the Official Gazette, not less than three months‘ notice of its intention so to do, may, by a like 
notification,  add  to  or  otherwise  amend  the  First  Schedule  for  the  purposes  of  this  Chapter  and  thereupon  the  said 
Schedule shall be deemed to be amended accordingly.] 

4[CHAPTER V 

MISCELLANEOUS 

5[6[33P.] Power to give directions.—The Central Government may give such directions to any State Government 
as may appear to the Central Government to be necessary for carrying into execution in the State any of the provisions of 
this Act or of any rule or order made thereunder.] 

34.  Offences  by  companies.—(1)  Where  an  offence  under  this  Act  has  been  committed  by  a  company,  every 
person who at the time the offence was committed, was in charge of, and was responsible to the company for the conduct 
of the business of the company, as well as the company shall be deemed to be guilty of the offence and shall be liable to 
be proceeded against and punished accordingly: 

Provided that nothing contained in this sub-section shall render any such person liable to any punishment provided 
in this Act if he proves that the offence was committed without his knowledge or that he exercised all due diligence to 
prevent the commission of such offence. 

(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by 
a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to 
any  neglect  on  the  part  of,  any  director,  manager,  secretary  or  other  officer  of  the  company,  such  director,  manager, 
secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and 
punished accordingly: 

1.  Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
2.  Ins. by Act 68 of 1982, s. 35, (w.e.f. 1-2-1968). 
3.  Subs. by Act 68 of 1982, s. 35, for cl. (f) (w.e.f. 1-2-1968). 
4.  Subs. by Act 11 of 1955, s. 16, for Chapter V. 
5..  Ins. by Act 35 of 1960, s. 11 (w.e.f. 16-3-1961). 
6.  S. 33A re-numbered as s. 33P by Act 13 of 1964, s. 27 (w.e.f. 15-9-1964). 
7. The word ―and‖ omitted by Act 26 of 2008, sec.18(i) (w.e.f. 10.08.2009) 
8. Sub. by Act 26 of 2008, s. 18(ii) (w.e.f. 10.08.2009)

32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

Explanation.—For the purposes of this section— 

(a) ―company‖ means a body corporate, and includes a firm or other association of individuals; and 

(b) ―director‖ in relation to a firm means a partner in the firm. 

1[34A. Offences by Government Departments.—Where an offence under Chapter 1V or Chapter 1VA has been committed 
by any department of Government, such authority as is specified by the Central Government to be in charge of manufacture, sale or 
distribution of drugs or where no authority is specified, the head of the department, shall be deemed to be guilty of the offence and 
shall be liable to be proceeded against and punished accordingly: 

Provided that nothing contained in this section shall render any such authority or person liable to any punishment provided in 
Chapter 1V or Chapter 1VA, as the case may be, if such authority or person proves that the offence was committed without its or his 
knowledge or that such authority or person exercised all due diligence to prevent the commission of such offence.] 

2[34AA. Penalty for vexatious search or seizure.—Any Inspector exercising powers  under this Act or the rules 

made thereunder, who,— 

(a) without reasonable ground of suspicion searches any place, vehicle, vessel or other conveyance; or 

(b) vexatiously and unnecessarily searches any person; or 

(c)  vexatiously  and  unnecessarily  seizes  any  drug  or  cosmetic,  or  any  substance  or  article,  or  any  record, 

register, document or other material object; or 

(d) commits, as such Inspector, any other act, to the injury of any person without having reason to believe that 

such act is required for the execution of his duty, 

shall be punishable with fine which may extend to one thousand rupees.] 

35. Publication of sentences passed under this Act.— (1) If any person is convicted of an offence under this Act, 3[the Court 
before  which  the  conviction  takes  place  shall,  on  application  made  to  it  by  the  Inspector,  cause]  the  offender‘s  name,  place  of 
residence,  the  offence  of  which  he  has  been  convicted  and  the  penalty  which  has  been  inflicted  upon  him,  to  be  published  at  the 
expense of such person in such newspapers or in such other manner as the Court may direct. 

(2) The expenses of such publication shall be deemed to form part of the cost relating to the conviction and shall be recoverable 

in the same manner as those costs are recoverable. 

36.  Magistrate‘s  power  to  impose  enhanced  penalties.—Notwithstanding  anything  contained  in  4[***]    5[the  Code  of 
Criminal Procedure, 1973 (2 of 1974)] it shall be lawful for 6[any Metropolitan Magistrate or any Judicial Magistrate of the first class] 
to pass any sentence authorised by this Act in excess of his powers under 4[*    *    *] the said Code. 

7[36A. Certain  offences  to  be  tried  summarily.—Notwithstanding  anything  contained  in  the  Code  of  Criminal 
Procedure, 1973 (2 of 1974), 8[all offences except the offences triable by the Special Court under Section 36-AB or Court 
of Sessions  under this  Act,]  punishable  with  imprisonment  for  a  term not  exceeding  three  years,  other  than  an offence 
under clause (b) of sub-section (1) of section 33-I, shall be tried in a summary way by a Judicial Magistrate of the first 
class specially empowered in this behalf by the State Government or by a Metropolitan Magistrate and the provisions of 
sections 262 to 265 (both inclusive) of the said Code shall, as far as may be, apply to such trial: 

Provided  that,  in  the  case  of  any  conviction  in  a  summary  trial  under  this  section,  it  shall  be  lawful  for  the 

Magistrate to pass a sentence of imprisonment for a term not exceeding one year: 

Provided  further  that  when  at  the  commencement  of,  or  in  the  course  of,  a  summary  trial  under  this  section  it 
appears to the Magistrate  that the nature of the case is  such  that a  sentence of  imprisonment  for a term exceeding one 
year may have to be passed or that it is, for any other reason, undesirable to try the case summarily, the Magistrate shall, 
after  hearing  the  parties,  record  an  order  to  that  effect  and  thereafter  recall  any  witness  who  has  been  examined  and 
proceed to hear or rehear the case in the manner provided by the said Code.] 

1.  Ins. by Act 13 of 1964, s. 28  (w.e.f. 15-9-1964). 
2.  Ins. by Act 68 of 1982, s. 36 (w.e.f. 1-2-1983). 
3.  Subs. by Act 68 of 1982, s. 37, for certain words  (w.e.f. 1-2-1983). 
4.  The words and figures ―section 32 of‖ omitted by Act 13 of 1964, s. 29 (w.e.f.15-9-1964). 
5.  Subs. by Act 68 of 1982, s. 38, for ―the Code of Criminal Procedure, 1898‖  (w.e.f. 1-2-1983). 
6.  Subs. by Act 68 of 1982, s. 38, for certain words (w.e.f. 1-2-1983). 
7.  Ins. by Act 68 of 1982,  s. 38, (w.e.f. 1-2-1983). 
8.  Sub. by Act 26 of 2008, s. 19 for all offences (w.e.f. 10.08.2009)

33 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

3[36-AB. Special Courts. – (1) The Central Government, or the State Government, in consultation with the Chief 
Justice  of  the  High  Court,  shall,  for  trial  of  offences  relating  to  adulterated  drugs  or  spurious  drugs  punishable  under 
clause (a) and (b) of Section 13, sub-section (3) of Section 22, clause (a) and (c) of Section 27, Section 28, Section 28-A, 
Section 28-B and clause (b) of sub-section (1) of Section 30 and other offences relating to adulterated drugs or spurious 
drugs, by notification, designate one or more Courts of Sessions as a Special Court or Special Courts for such area or for 
such case or class or group of cases as may be specified in the notification.  

Explanation.- In this sub-section, ―High Court‖  means the  High Court of the State in  which a Court of Sessions 

designated as Special Court was functioning immediately before such designation.  

(2) While trying an offence under this Act, a Special Court shall also try an offence, other than an offence referred 
to in sub-section (1), with which the accused may, under the Code of Criminal Procedure, 1973 (2 of 1974), be charged at 
the same trial.] 

3[36-AC. Offences to be cognizable and non-bailable in certain cases. –  
(1) Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974)-  

(a)  every  offence,  relating  to  adulterated  or  spurious  drug  and  punishable  under  clause  (a)  and  (c)  of  sub-
section (1) Section 13, clause (a) of sub-section (2) of Section 13, subsection (3) of Section 22, clause (a) and 
(c) of Section 27, Section 28, Section 28A, 40 Section 28B and sub-section (1) and (2) of Section 30 and 
other offences relating to adulterated drugs or spurious drugs, shall be cognizable. 
(b)  no person  accused,  of  an  offence  punishable  under  clause  (a)  and  (c) of  sub-section  (1)  of  Section  13, 
clause (a) of sub-section (2) of Section 13, sub-section (3) of Section 22, clause (a) and (c) of Section 27, 
Section 28, Section 28A, Section 28B and subsection (1) and (2) of Section 30 and other offences relating to 
adulterated drugs or spurious drugs, shall be released on bail or on his own bond unless-  
(i)   the Public Prosecutor has been given an opportunity to oppose the application for such release; and 
(ii)  where  the  Public  Prosecutor  opposes  the  application,  the  court  is  satisfied  that  there  are  reasonable 
grounds  for  believing  that  he  is  not  guilty  of  such  offence  and  that  he  is  not  likely  to  commit  any 
offence while on bail:  

Provided that a person, who, is under the age of sixteen years,or is a woman or is sick or infirm, may be released 

on bail, if the Special Court so directs.  

(2) The limitation on granting of bail specified in clause (b) of sub-section (1) is in addition to the limitations under 

the Code of Criminal Procedure, 1973 (2 of 1974) or any other law for the time being in force on granting bail.  

(3) Nothing contained in this section shall be deemed to affect the Special powers of the High Court regarding bail 
under Section 439 of the Code of Criminal Procedure, 1973 (2 of 1974) and the High Court may exercise such powers 
including the power under clause (b) of sub-section (1) of that section as if the reference to ―Magistrate‖ in that section 
includes also a reference to ―Special Court‖ designated under Section 36AB.]  

3[36-AD. Application Code of Criminal Procedure, 1973 to proceedings before Special Courts. – (1) Save as 
otherwise  provided  in  this  Act,  the  provisions  of  the  Code  of  Criminal  Procedure,  1973  (2  of  1974)  (including  the 
provisions  as  to  bails  and  bonds),  shall  apply  to  the  proceedings  before  a  Special  Courts  and  for  the  purpose  of  said 
provisions, the Special Court shall be deemed to be a Court of Sessions and the person conducting the prosecution before 
the Special Court, shall be deemed to be a Public Prosecutor:  

Provided that the Central Government or the State Government may also appoint, for any case or cases or group of 

cases, a Special Public Prosecutor.  

(2) A person shall not be qualified to be appointed as Public Prosecutor or a Special Public Prosecutor under this 
section unless he has been in practice as an advocate for not less than seven years, under the Union or a State, requiring 
special knowledge of law.  

(3)  Every  person  appointed  as  a  Public  Prosecutor  or  a  Special  Public  Prosecutor  under  this  section  shall  be 
deemed to be a Public Prosecutor within the meaning of clause (u) of 41 Section 2 of the Code of Criminal Procedure, 
1973 (2 of 1974) and the provisions of that Code shall have effect accordingly.] 

3[36AE.  Appeal  and  revision.-  The  High  Court  may  exercise,  so  far  as  may  be  applicable,  all  the  powers 
conferred by Chapter XXIX or Chapter XXX of the Code of Criminal Procedure, 1973(2 of 1974), on a High Court, as if 
a Special Court within the local limits of  the jurisdiction of the High Court were a Court of Session trying cases within 
the local limits of the jurisdiction of the High Court.] 

37. Protection of action taken in good faith.—No suit, prosecution or other legal proceeding shall lie against any 

person for anything which is in good faith done or intended to be done under this Act. 

1[38. Rules to be laid before Parliament.— Every rule made under this Act shall be laid as soon as may be after 
it is made before each House of Parliament while it is in session for a total period of thirty days which may be comprised 
in one session or in two or more successive sessions, 2[and if, before the expiry of the session immediately following the 
session or the successive sessions aforesaid], both Houses agree in making any modification in the rule or both Houses 
agree that the rule should not be made, the rule shall thereafter have effect only in such modified from or be of no effect, 
as  the  case  may  be;  so  however  that  any  such  modification  or  annulment  shall  be  without  prejudice  to  the  validity  of 
anything previously done under that rule.] 

1.  Ins. by Act 13 of 1964, s. 30  (w.e.f. 15-9-1964). 
2.  Subs. by Act 68 of 1982, s. 40, for certain words  (w.e.f. 1-2-1983). 
3. Ins. by Act 26 of 2008, s. 20 (w.e.f. 10.08.2009)

34 

 
 
 
 
Drugs and Cosmetics Act, 1940 

1[THE FIRST SCHEDULE 

[See section 3(a)] 

2[A.—AYURVEDIC AND SIDDHA SYSTEMS] 

Serial No.                               Name of book 

Ayurveda 

1.                                        Arogya Kalpadruma 
2.                                        Arka Prakasha 
3.                                        Arya Bhishak 
4.                                        Ashtanga Hridaya 
5.                                        Ashtanga Samgraha 
6.                                        Ayurveda Kalpadruma 
7.                                        Ayurveda Prakasha 
8.                                        Ayurveda Samgraha 
9.                                        Bhaishajya Ratnavali 
10.                                      Brihat Bhaishajya Ratnakara 
11.                                      Bhava Prakasha 
12.                                      Brihat Nighantu Ratnakara 
13.                                      Charaka Samihita 
14.                                      Chakra Datta 
15.                                      Gada Nigraha 
16.                                      Kupi Pakva Rasayana 
17.                                      Nighantu Ratnakara 
18.                                      Rasa Chandanshu 
19.                                      Rasa Raja Sundara 
20.                                      Rasaratna Samuchaya 
21.                                      3[Rasatantra Sara Va Siddha Prayoga Sangraha—Part 1] 
4[21 (a)                                Rasatantra Sara Va Siddha Prayoga Sangraha—Part II (Edition 2006)] 
22.                                      Rasa Tarangini 
23.                                      Rasa Yoga Sagara 
24.                                      Rasa Yoga Ratnakara 
25.                                      Rasa Yoga Samgraha 
26.                                      Rasendra Sara Samgraha 
27.                                      Rasa Pradipika 
28.                                      Sahasrayoga 
29.                                      Sarvaroga Chikitsa Ratnam 
30.                                       Sarvayoga Chikitsa Ratnam 
31.                                      Sharangadhara Samhita 
32.                                      Siddha Bhaishajya Manimala 
33.                                      Siddha Yoga Samgraha 
34.                                      Sushruta Samhita 
35.                                      Vaidya Chintamani 
36.                                      Vaidyaka Shabda Sindu 
37.                                      Vaidyaka Chikitsa Sara 
38.                                      Vidya Jiwan 
39.                                      Vasava Rajeeyam 
40.                                      Yoga Ratnakara 
41.                                      Yoga Tarangini 
42.                                      Yoga Chintamani 
43.                                      Kashyapasamhita 
44.                                      Bhelasamhita 
45.                                      Vishwanathachikitsa 
46.                                      Vrindachikitsa 

1.  Subs. by Act 13 of 1964, s. 31, for the Sch. The First Schedule came into force with effect from 1-2-1969 and the Second Schedule came into force 

with effect  from the 15th September, 1964. 

2.  Subs. by Act 68 of 1982, s. 41 (w.e.f. 1-2-1983). 
3.  Subs. by Notification No. G.S R. 658 (E), dated 31-08-1994. 
4. Added by G.S R. 337 (E), dated 15-04-2010 (w.e.f. 20.4.2010).

35 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

Serial  No.                              Name of book 

47.                                           Ayurvedachintamani 
48.                                           Abhinavachintamani 
49.                                           Ayurveda-Ratnakara 
50.                                           Yogaratnasangraha 
51.                                           Rasamrita 
52.                                           Dravyagunanighantu 
53.                                           Rasamanjari 
54.                                           Bangasena 
1[54A                                         6 [ Ayurvedic Formulary of India and its Parts) 
54B                                         Ayurveda Sara Samgraha] 
2[54C                                         Ayurvedic Pharmacopoeia of India.] 
5[54D. 

  Ayurvedic Pharmacopoeia of India and its Parts.] 

Siddha 

55                                            Siddha Vaidya Thirattu 
56                                            Therayar Maha Karisal 
57                                            Brahma Muni Karukkadai (300) 
58                                            Bhogar (700) 
59                                            Pulippani (500) 
60                                            Agasthiyar Paripuranam (400) 
61                                            Therayar Yamagam 
62                                            Agasthiyar Chenduram (300) 
63                                            Agasthiyar (1500) 
64                                            Athmarakshamrutham 
65                                            Agasthiyar Pin (80) 
66                                            Agasthiyar Rathna Churukkam 
67                                            Therayar Karisal (300) 
68                                            Veeramamuni Nasa Kandam 
69                                            Agasthiyar (600) 
70                                            Agasthiyar Kanma Soothiram 
71                                            18 Siddar‘s Chillarai Kovai 
72                                            Yog Vatha Kaviyam 
73                                            Therayar Tharu 
74                                            Agasthiyar Vaidya Kaviyam (1500) 
75                                            Bala Vagadam 
76                                            Chimittu Rathna (Rathna) Churukkam 
77                                            Nagamuni (200) 
78                                            Agasthiyar Chillarai Kovai 
79                                            Chikicha Rathna Deepam 
80                                            Agasthiyar Nayana Vidhi 
81                                            Yugi Karisal (151) 
82                                            Agasthiyar Vallathi (600) 
83                                            Therayar Thaila Varkam 

31[84                                            Siddha Formulary of India (Part I)] 

5[85                                            Siddha Formulary of India and its Parts] 

4[B.—UNANI  TIBB SYSTEM] 

Serial No.                                    Name of book 
1                                                  Karabadin Qadri 
2                                                  Karabadin Kabir 
3                                                  Karabadin Azam 
4                                                  Ilaj-ul-Amraz 
5                                                  Al Karabadin 
6                                                  Biaz Kabir Vol. II 
7                                                  Karabadin Jadid 
8                                             Kitab-ul-Taklis 
9                                             Sanat-ul-Taklis 
10                                           Mifta-ul-Khazain 
11                                           Madan-ul-Aksir 
12                                           Makhzan-ul-murabhat 
1[13                                         National Formulary of Unani Medicine 7[****]] 
8[14                                         Unani Pharmacopoeia of India] 

1.  Ins. by Notifn. No. G.S.R. 735 (E), dated the 28th August, 1987.         6. Subs. by G.S R. 337 (E), dated 15-04-2010 (w.e.f. 20.4.2010). 
2.  Ins. by Notifn. No. G.S.R. 423 (E), dated the 11th June, 2002.             7.  Omitted by GSR 780(E), dt 25-11-2004. 
3.  Ins. by Notifn. No. G.S.R. 735 (E), dated the 28th August, 1987.         8. Ins by GSR 780 (E), dt. 25.11.20114. 
4.  Subs. by Act 68 of 1982, s. 41 (w.e.f. 1-2-1983). 
5. Ins. by G.S R. 337 (E), dated 15-04-2010 (w.e.f. 20.4.2010).  

36 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

4[THE SECOND SCHEDULE  

(See sections  8 and 16) 

STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS  MANUFACTURED FOR SALE, SOLD, 
STOCKED OR EXHIBITED FOR SALE OR DISTRIBUTED 

Class of drug                                                       Standard to be complied with 

1                                                                                        2

1.   Patent   or   proprietary   medicines   1[other   than 
Homoeopathic medicines] 

2.  2[Substances  commonly  known  as  vaccines,  sera 
toxins,    toxoids,    antitoxins    and    antigens    and 
biological  products  of  like  nature,  for  human  use  or 
for veterinary use. 

3[*  *    *   *] 

4. Substances (other than food) intended to affect the 
structure  or  any  function  of  the  human  body  or 
intended  to be used  for  the destruction of  vermin  or 
insects  which  cause  disease  in  human  beings  or 
animals. 

5[1[4-A. Homoeopathic Medicines. 

(a)  Drugs  included  in  the  Homoeopathic 

Pharmacopoeia of India. 

(b)  Drugs not included in the Homoeopathic 
Pharmacopoeia  of  India  but  which  are 
included 
Homoeopathic 
the 
Pharmacopoeia  of  United  States  of 
America  or  the  United  kingdom  or  the 
German Homoeopathic Pharmacopoeia. 

in 

(c)  Drugs not included in the Homoeopathic 
Pharmacopoeia  of  India  or  the  United 
States  of  America,  or 
the  United 
Kingdom  or  the  German  Homoeopathic 
Pharmacopoeia. 

The  formula  of  list  of  ingredients  displayed  in  the 
prescribed  manner  on  the  label  of  the  container  and 
such other standards as may be prescribed. 

The  standards  maintained  at 
the  International 
Laboratory for Biological Standards, Stantans Serum 
Institute,  Copenhagen  and  at  the  Central  Veterinary 
Laboratory, Weybridge Surrey, U.K., and such other 
the  World  Health 
laboratories 
Organization  from  time  to  time,  and  such  further 
standards  of  strength,  quality  and  purity,  as  may  be 
prescribed.] 

recognized  by 

Such standards as may be prescribed. 

Standards of identity, purity and strength specified in 
the  edition  of  the  Homoeopathic  Pharmacopoeia  of 
India  for  the  time  being  and  such  other  standards  as 
may be prescribed. 

Standards  of  identity,  purity  and  strength  prescribed 
for  the  drugs  in  the  edition  of  such  Pharmacopoeia 
for the time being in  which they are given and such 
other standards as may be prescribed. 

The  formula  or  list  of  ingredients  displayed  in  the 
prescribed manner on the label of the containder and 
such  other  standards  as  may  be  prescribed  by  the 
Central Government].] 

1.  Ins. by Notifn. No. S.O. 887, dated the 19th March 1966, Gazette of India , Pt.   II, Sec. 3 (ii), p. 819. 
2.  Subs. by Notifn. No. G.S.R. 299(E), dated  the 23rd April 1984. 
3.  Entry 3 omitted  by Notifn. No. G.S.R. 299(E), dated the 23rd April, 1984. 
4. Subs. by Act 13 of 1964, S. 31, for the Schedule. 
5. Subs. by G.S.R. 820 (E), dt. 6-6-1978, for item 4A, earlier Ins. by Notifn. No. S.O. 887, dated the 19th March 1966, Gazette of India , Pt.   
II, Sec. 3 (ii), p. 819.

37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

Class of drug                                                   Standard to be complied with 

1                                                                                   2 

1[5. Other drugs: 

(a) Drugs included in the Indian Pharmacopoeia 

Standards  of  identity,  purity  and  strength  specified 
in  the  edition  of  the  Indian  Pharmacopoeia  for  the 
time being in force and such other standards as may 
be prescribed. 

In case the standards of identity, purity and strength 
for  drugs  are  not  specified  in  the  edition  of  the 
Indian  Pharmacopoeia  for  the  time  being  in  force 
but  are  specified  in  the  edition  of  the      Indian 
pharmacopoeia 
the 
standards  of  identity,  purity  and  strength  shall  be 
those  occurring  in  such  immediately  preceding 
edition of the Indian Pharmacopoeia  and such other 
standards as may be prescribed. 

  immediately 

  preceding, 

in 

Standards  of  identity,  purity  and  strength  specified 
for  drugs 
such  official 
the  edition  of 
Pharmacopoeia  of  any  other  country  for  the  time 
being  in  force  and  such  other  standards  as  may  be 
prescribed. 

not 

Indian 
included 
(b)  Drugs 
Pharmacopoeia  but  which  are  included  in  the 
official Pharmacopoeia of any other country. 

the 

in 

In case the standards of identity, purity and strength 
for  drugs  are  not  specified  in  the  edition  of  such 
official  Pharmacopoeia  for  the  time  being  in  force, 
but  are  specified 
immediately 
preceding,  the  standards  of  identity,  purity  and 
strength    shall    be    those    occurring    in    such 
immediately 
official 
Pharmacopoeia  and such other standards as may be 
prescribed.]]

the  edition 

preceding 

such 

of 

in 

1. Subs. by Notifn. No. G.S.R. 885, dated  the 4th August, 1973, Gazette of India, Pt. II, s. 3(i), p. 1643, for item 5.

38 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules, 1945 

[21st  December 1945] 

Notificaiton: No. F. 28-10/45-H (1). _In exercise of the powers conferred by 1[sections 6(2), 
12, 33 and 33N] of the Drugs and Cosmetics Act, 1940 (XXIII of 1940), the Central 
Government is pleased to make the following Rules:-  

PART I 
PRELIMINARY

1.  Short  title,  extent  and  commencement. 

Drugs 9[and Cosmetics] Rules, 1945. 

 (2) They extend to the whole of India. 2[***] 

10[***] 

(1)  These  Rules  may  be  called  the

2. Definitions. 

In these Rules, unless there is anything repugnant in the subject or

context 

(a) ―the Act‖ means the Drugs and Cosmetics Act, 1940 (XXIII of 1940) as 

amended from time to time; 

3[(b)  ―Central  Licence  Approving  Authority‖  means  the  Drugs  Controller, 

India, or the Joint Drugs Controller (India) or the Deputy Drugs Controller (India) 
appointed by the Central Government;] 

(c) ―Director‖ means the Director of the Central Drugs Laboratory; 

(d)  ―Form‖ means a form set forth in Schedule A; 

4[(dd)  Homoeopathic  medicines  include  any  drug  which  is  recorded  in 
Homoeopathic provings  or  therapeutic efficacy  of  which  has  been  established 
through  long  clinical  experience  as  recorded  in  authoritative  Homoeopathic 
literature of India and abroad and which is prepared according to the techniques 
of  Homoeopathic  pharmacy  and  covers  combination  of  ingredients  of  such 
Homoeopathic   medicines   but   does   not   include   a   medicine   which   is 
administered by parenteral route;] 

(e) ―Laboratory‖ means the Central Drugs Laboratory; 
5[(ea) ―registered Homoeopathic medical practitioner‖ means a person who 
is registered in the Central Register or State Register of Homoeopathy;] 
8
[(eb)―Phytopharmaceutical drug‖ includes purified and standardised fraction 
with  defined  minimum  four  bio-active  or  phyto-chemical  compounds 
(qualitatively and quantitatively  assessed) of an extract of a medicinal plant or 
its part, for internal or external use of human beings or animals for diagnosis, 
treatment,  mitigation  or  prevention  of  any  disease  or  disorder  but  does  not 
include administration by parenteral route.] 

6[(ee) ―Registered medical practitioner‖ means a person 

(i)  holding a  qualification granted by  an  authority specified or  notified 
under  section  3  of  the Indian Medical Degrees  Act, 1916 (7 of 1916), or 
specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 
1956); or 

(ii)  registered  or  eligible  for  registration  in  a  medical  register  of  a 
State meant for the registration of persons practising the modern scientific 
system of medicine  7[excluding the Homoeopathic system of medicine]; or 

1.  Subs. by G.S.R. 370(E), dt. 7-4-1994.             2.  Omitted by G.S.R. 358, dt. 15-3-1975. 
3.  Sub. by GSR. 579(E), dt. 20-9-2006, earlier Ins. by  G.S.R. 923(E), dt. 14-12-1992.         
4.  Ins. by Notfn. No. F. 1-59 / 68-D, dt. 19-11-1969. 
5.  Ins. by G.S.R 680 (E), dt. 5-12-1980.              6.  Ins. by Notfn.  F. 1-22 / 59-D, dt. 9-4-1960. 
7.  Ins. by S.O. 2139, dt. 15-6-1972.                     8.  Ins. By G.S.R 918(E), dt. 30-11-2015.  
9. Ins. by GSR 1183(E), dt 17-8-1964.                 10. Sub-rule  (3) omitted by GSR 19, dt. 15-12-1977. 

39 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

 (iii)  registered  in  a  medical  register,  1[other  than  a  register  for  the 
registration of Homoeopathic practitioner], of a State, who although not falling 
within sub-clause (i) or sub-clause (ii) is declared by a general or special order 
made by the State Government in this behalf as a person practising  the  modern 
scientific  system  of  medicine  for  the  purposes of this Act; or 

(iv) registered or eligible for registration in the register of dentists for a 

State under the Dentists Act, 1948 (16 of 1948); or 

(v)  who  is  engaged  in  the  practice  of  veterinary  medicine  and  who 

possesses qualifications approved by the State Government;] 

2[(f)  ―retail  sale‖  means  a  sale  3[whether  to  a  hospital,  or  dispensary,  or  a 
medical, educational or  research institute  or  to  any  other  person]  other  than  a 
sale by way of wholesale dealing]; 

4[(g)  ―sale  by  way  of  wholesale  dealing‖  means  sale  to  a  person  for  the 
purpose  of  selling  again  and  includes  sale  to  a  hospital,  dispensary,  medical, 
educational or research institution;] 

5[(h) ―Schedule‖ means a Schedule to these Rules;] 
6[(i)   State   Government   in   relation   to   a   Union   Territory   means   the 

Administrator thereof; 

9[***] 

PART II 

THE CENTRAL DRUGS LABORATORY 

3. Functions. 

It shall be the function of the Laboratory

(i)  to  analyse  or  test  such  samples  of  drugs  as  may  be  sent  to  it  under  sub- 

section (2) of section 11, or under sub-section (4) of section 25 of the Act; 

7[*   *    *    *  *] 

(iii)  to  carry  out  such  other  duties      as  may  be  entrusted  to  it  by  the  Central 
Government  or,  with  the  permission  of  the  Central  Government,  by  a  State 
Government after consultation with the Drugs Technical Advisory Board. 
8[3A.    (1)The  functions  of  the  Laboratory  in  respect  of  the  following  drugs    or 
classes of drugs shall be carried out at the Central Research Institute, Kasauli, and the 
functions  of  the  Director  in  respect  of  the  said  drugs  or  classes  of   drugs  shall  be 
exercised by the Director of the said Institute : 

(1)      Sera. 

(2)      Solution of serum proteins intended for injection. 

(3)      Vaccines. 

(4)      Toxins.    

(5) Antigens. 

1.  Ins. by S.O. 2139, dt. 5-6-1972. 
2  Subs. by Notfn. No. F. 1-3/51-DS., dt. 15-11-1954. 
3.  Ins. by  G.S.R 681 (E), dt. 6-6-1988. 
4. Subs. by Notfn. F-1-16/57, dt. 15.6.1957. 
5.  Subs. by Notfn. No. F. 28-10/45-H (1), dt. 31-3-1957. 
6.  Subs. by  Notfn. No. F-1-16/57-D, dt. 15-6-1957. 
7.  Cl. (ii) omitted, by  Notfn. No. F-1-16/57-D, dt. 15-6-1957. 
8  Ins. by  Notfn. No. F. 4-1 / 60-D, dt. 15-5-1961. 
9. Cl. (j) omitted by GSR 592(E), dt. 13-08-2008 

40 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

 (6) Anti-toxins. 

(7)      Sterilized surgical ligature and sterilised surgical suture. 

(8)    Bacteriophages: 

1[Provided that the functions of the Director in respect of Oral Polio Vaccine shall 
be  exercised  by  the  Deputy  Director  and  Head  of  the  Polio  Vaccine  Testing 
Laboratory in case of  Central Research Institute, Kasauli only.] 

2[(1A) The functions of the Laboratory in respect of   Oral Polio Vaccine shall be 
carried out by the following Institutes and the functions of the Director in respect of 
the said drugs shall be exercised by the Director of the respective Institutes :- 

(a)  Pasteur Institute of India, Coonoor. 

(b)  Enterovirus  Research  Centre  (Indian  Council  of  Medical  Research), 

Haffkin Institute Compound, Parel, Bombay-400012.] 

3[(c) The National Institute of Biologicals, NOIDA.] 

4[(2) The functions of the Laboratory in respect of the following drugs or classes of 
drugs  shall  be  carried  out  at  the  Indian  Veterinary  Research  Institute,  Izatnagar  or 
Mukteshwar and the functions of the Director in respect of the said drugs or classes of 
drugs shall be exercised by the Director of either of the said institutes. 

(1)    Anti-sera for veterinary use. 

(2)    Vaccines for veterinary use. 

(3)    Toxoids for veterinary use. 

(4)    Diagnostic Antigens for veterinary use.] 

5[(3)  The  functions  of  the  laboratory  in  respect  of  testing  of  condoms  shall  be 
carried  out  at  the  Central  Drugs  Testing  Laboratory,  Chennai,  and  the  functions  of 
the Director in  respect of the  said products shall be  exercised by  the  Director of  the 
said Laboratory.] 

6[(4)]  The  functions  of  the  Laboratory  in  respect  of  the  following  drug  shall  be 
carried  out  at  the  Laboratory  of  the  Serologist  and  Chemical  Examiner  to  the 
Government of India, Calcutta and the functions of the Director in respect of the said 
drug  shall  be  performed  by  the  Serologist  and  Chemical  Examiner  of  the  said 
Laboratory : 

         VDRL Antigen. 

     7[(5) The function of the Laboratory in respect of Intra-Utrine Devices and Falope 
Rings  shall  be  carried  out  at  the  Central  Drugs  Testing  Laboratory,  Thane, 
Maharashtra and  the functions of  the  Director in  respect of  the  said devices shall be 
exercised by the Director of the said Laboratory.] 

1.  Subs. by G.S.R.445(E), dt. 30-4-1992. Earlier Ins. by G.S.R.62(E), dt. 15-2-1982. 
2.  Ins. by G.S.R. 445(E), dt. 30-4-1992. 
3.  Ins. by G.S.R.249(E), dt. 4-4-2002. 
4.  Ins. by Notfn. No. F.-1-6/62-D, dt. 2-7-1969. 
5.  Sub. By G.S.R. 651(E), dt. 9-9-2009, earlier Ins. by S. O. No. 2139, dt. 12-8-1972. 
6.  Sub-rule (4) omitted and sub-rule (5) renumbered as sub-rule (4) by  Notfn. No. G.S.R. 62(E), 

dt. 15-2-1982. 

7. Subs. by  G.S.R 242(E), dt. 18-3-1998. Earlier Ins. by G.S.R. No. 865 (E), dt. 25-10-1990. 

41 

 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(6) The functions of the Laboratory in respect of human blood and human blood 
products  including  components,  to  test  for  freedom  of  HIV  antibodies,  shall  be 
carried out  by  the  following Institutes/Hospitals and  the  functions of  the  Director in 
respect  of  the  above  mentioned  products  shall  be  exercised  by  the  head  of  the 
respective Institute, namely:- 

(a)    National    Institute    for    Communicable    Disease,    Department    of 

Microbiology, Delhi. 

(b) National Institute of Virology, Pune 

(c)  Centre  of  Advanced  Research  in  Virology,  Christian  Medical  College, 

Vellore.] 

2[(7) The functions of the Laboratory in respect of  Homoeopathic medicines shall 
be  carried  out  at  the  Homoeopathy  Pharmacopoeia  Laboratory,  Ghaziabad  and  the 
functions of the Director in respect of the Homoeopathic medicines shall be exercised 
by the Director of the laboratory.] 

3[(8) (a) The functions of the Laboratory in respect of the following kits or class of 
drugs  shall  be  carried  out  at  the  National  Institute  of  Biologicals,  Noida  and  the 
functions  of  the  Director  in  respect  of  the  said  drugs  or  class  of  drugs  shall  be 
exercised by the Director of the said institute.  

(b) The kits or class of drugs referred to in clause (a) are-  
(1) Blood grouping reagents.  
(2) Diagnostic kits for human immunodeficiency virus, Hepatitis B Surface Antigen 

and Hepatitis C Virus. 
(3) Blood products-  

(a) Human Albumin;  
(b) Human Normal Immunoglobulin (intramuscular and intravenous);  
(c) Human Coagulation Factor VIII;  
(d) Human Coagulation Factor IX;  
(e) Plasma Protein Fractionation;  
(f) Fibrin Sealant Kit; 
(g) Anti Inhibitor Coagulation complex. 

(4) Recombinant products such as- 

(a) Recombinant insulin and insulin analogue; 
(b) r-erythropoietin (EPO); 
(c) r-Granulocyte Colony stimulating Factor (G-CSF). 

(5) Biochemical kits- 

(a) Glucose Test Strips; 

(b) Fully Automated analyzer based glucose reagents.] 

4.  Despatch  of  samples  for  test  or  analysis.-  (1)  Samples  for  test  or  analysis under 
sub-section (4)  of  section  25  of  the  Act  shall  be  sent  by  registered post  in  a  sealed 
packet,  enclosed,  together  with  a  memorandum  in  Form  1,  in  an  outer  cover 
addressed to the Director. 

(2)  The  packet  as  well as  the  outer  cover, shall  be  marked with  a  distinguishing 

number. 

(3) A copy of the memorandum in Form 1 and a specimen impression of the seal used 
to seal the packet shall be sent separately by registered post to the Director. 

5. Recording of condition of seals. 
On receipt of the packet, it shall be opened by an  officer authorised in  writing  in  that 
behalf  by  the  Director who  shall  record  the condition of the seal on the packet. 

          1.  Ins. by G.S.R 16(E), dt. 10-1-1990.                   2.  Ins. by  G.S.R 246(E), dt. 1-5-1991. 

3.  Sub. by G.S.R. No. 908(E), dt. 4-4-2014. Earlier Ins. by G.S.R. No. 249 (E), dt. 4-4-2002.

42 

 
 
 
 
 Drugs and Cosmetics Rules 1945 

6. Report of result of test or analysis.  After test or analysis the result of the test or
analysis, together with  full protocols of the tests applied, shall be supplied forthwith 
to the sender in Form 2. 

7. Fees.  The fees for test and analysis shall be those specified in Schedule B.

8.   Signature  of   certificates. 

Certificates  issued   under   these   Rules   by   the
Laboratory shall be signed by the Director or by an officer authorised by the Central 
Government by Notification in the Official Gazette to sign such certificates. 

1[PART  III 

[RULES 9 to 20- omitted by SRO. 2136 dated 15-06-1957] 

PART IV 
2[IMPORT AND REGISTRATION] 

21. In this Part.– 

3[(a) ―import licence‖ means either a licence in Form 10 to import drugs  4[* * 
*];  excluding  those  specified  in  Schedule  X,  or  a  licence  in  Form  10-A  to 
import drugs specified in Schedule X;] 

(b)  ―licensing  authority‖  means  the  authority  appointed  by  the  Central 
Government to perform the duties of the licensing authority under these Rules and 
includes  any  person  to  whom  the  powers  of  a  licensing  authority  may  be 
delegated under Rule 22; 

(c) ―licence for examination, test or analysis‖ means a licence in Form 11 to 
import small  quantities of drugs the  import of  which is  otherwise prohibited, for 
the purpose of examination, test or analysis; 

5[(d)  ―manufacturer‖  includes  a  manufacturer  of  drugs,  who  may  be  a 
Company  or  a  unit  or  a  body  corporate  or  any  other  establishment in  a  country 
other  than  India,  having  its  drugs  manufacturing facilities  duly  approved  by  the 
National  Regulatory  Authority  of  that  country,  and  who  also  has  a  free  sale 
approval of the drugs approved by the said authority in the concerned country, and 
/or in other major countries; 

(e)  ―Registration  Certificate‖  means  a  certificate  issued  under  Rule  27A  by 
the  licensing authority in  Form 41  for  registration of  the  premises and  the  drugs 
manufactured by the manufacturer meant for import into and use in India.] 

22. The licensing authority may with the approval of the Central Government by an 
order in writing delegate the 2[power to sign licences and Registration Certificate and] 
such  other  powers  as  may  be  specified  in  the  order  to  any  other  person  under  his 
control. 

1.  Part III (Rules 9 to 20) omitted by Notfn. No. F. 1-16/57-D (SRO 2136), dt. 15-6-1957. 
2.  Sub. by G.S.R 604 (E), dt. 24-8-2001. 
3.  Subs. by  G.S.R  462 (E),dt. 22-6-1982. 
4.  Omitted  by G.S.R 604 (E), dt. 24-8-2001. 
5. Ins. by G.S.R 604 (E), dt. 24-8-2001.

43 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[23. Import licences.–An import licence in Form 10 shall be required for 2 [import 
of drugs], excluding those specified in Schedule X, and an import licence in Form 10- 
A shall be required for the import of drugs specified in Schedule X.] 

2[24.  Form  and  manner of  application for  import licence.– (1)  An  application for 
an  import  licence  shall  be  made  to  the  licensing  authority  in  Form  8  for  drugs 
excluding  those  specified  in  Schedule  X,  and  in  Form  8A  for  drugs  specified  in 
Schedule X, either by  the manufacturer himself having a  valid wholesale licence for 
sale  or  distribution  of  drugs  under  these  Rules,  or  by  the  manufacturer‘s  agent  in 
India either having a valid licence under the Rules to manufacture for sale of a drug 
or having a valid wholesale licence for sale or distribution of drugs under these Rules, 
and  shall be accompanied by  a  licence fee  of  one thousand rupees for a  single drug 
and an additional fee at the rate of one hundred rupees for each additional drug and by 
an undertaking in Form 9 duly signed by or on  behalf of the manufacturer: 

Provided that in the case of any subsequent application made by the same importer 
for  import  licence  for  drugs  manufactured  by  the  same  manufacturer,  the  fee  to 
accompany each such application shall be one hundred rupees for each drug: 

(2) Any application for import licence in Form 8 or Form 8-A, as the case may be, 
shall be accompanied by  a  copy of  Registration Certificate  issued in  Form 41  under 
Rule 27A: 

Provided  that  in  case  of  emergencies  the  licensing  authority  may,  with  the 
approval of the  Central Government, issue an  import licence in  Form 10  or  10A, as 
the case may be, without the issuance of Registration Certificate under Rule 27A, for 
reasons to be recorded in writing. 

3[Provided  further  that  Registration  certificate  shall  not  be  required  to  be 
accompanied with an application for an import licence under the Rules for the import 
of  in-vitro  diagnostic  kits  and  regents,  except  for  the  diagnostic  kits  notified  from 
time to time under sub-clause (iv) of clause (b) of section 3.] 

(3) A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the 

licence issued under this Rule, if the original is defaced, damaged or lost.] 

4[24A.  Form  and  manner  of  application  for  Registration  Certificate.—(1)  An 
application  for  issue  of  a  Registration  Certificate  shall  be  made  to  the  licensing 
authority  in  Form  40,  either  by  the  manufacturer  himself,  having  a  valid  wholesale 
licence  for  sale  or  distribution  of  drugs  under  these  rules,  or by his authorised agent 
in India, either having a valid licence under the rules to manufacture for sale of a drug 
or having a valid wholesale licence for sale or distribution of drugs under these rules, 
and shall be accompanied by the fee specified in sub-rule (3) and the informations and 
undertakings specified in Schedules D-I and D-II duly signed by or on behalf of the 
manufacturer. 

1.  Subs. by  G.S.R. 462 (E), dt. 22-6-1982. 
2.  Subs. by  G.S.R 604 (E), dt. 24-8-2001. 
3. Ins. by  G.S.R. 35(E), dt. 20.1.2005. 
4. Ins. by G.S.R 604 (E), dt. 24-08-2001.

44 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(2) The authorisation by a manufacturer to his agent in India shall be documented 
by a power of attorney executed and authenticated either in India before a First Class 
Magistrate,  or  in the country  of  origin    before   such    an    equivalent  authority,  the 
certificate  of  which  is  attested  by  the  Indian  Embassy  of  the  said  country,  and  the 
original  of  the  same  shall  be  furnished  along  with  the  application  for  Registration 
Certificate. 

(3)  (i)  A  fee  of  one  thousand  and  five  hundred  US  dollars  1[or  its  equivalent  in 
Indian rupees] shall be paid along with the application in Form 40 as registration fee 
for his premises meant for manufacturing of drugs intended for import into and use in 
India 

(ii) A fee of one thousand US dollars 1[or its equivalent in Indian rupees] shall be 
paid along with the application in Form 40 for the registration of a single drug meant 
for import into and use in India and an additional fee at the rate of one thousand US 
dollars for each additional drug: 

Provided  that  in  the  case  of  any  subsequent  application  for  registration  of 
additional  drugs  by  the  same  manufacturer,  the  fee  to  accompany  shall  be  one 
thousand US dollars 1[or its equivalent in Indian rupees] for each drug. 

(4)  The  fees  shall  be  paid  through  a  Challan  in  the  Bank  of  Baroda,  Kasturba 
Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, 
or  any  other bank, as  notified, from time  to  time,  by  the  Central Government, to  be 
credited  under  the  Head  of  Account  ―0210-Medical  and  Public  Health,  04-Public 
Health, 104-Fees and Fines‖: 

Provided that in  the  case  of  any  direct payment of  fees by  a  manufacturer in the 
country of origin, the fees shall be  paid through Electronic Clearance System (ECS) 
from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, 
New Delhi, through the Electronic Code of the bank in the Head of Account ―0210- 
Medical and  Public  Health, 04-  Public  Health, 104-Fee and  Fines‖, and  the  original 
receipt  of  the  said  transfer  shall  be  treated  as  an  equivalent  to  the  bank  challan, 
subject to the approval by the Bank of Baroda that they have received the payment. 

(5)  The  applicant  shall  be  liable  for  the  payment  of  a  fee  of  five  thousand  US 
dollars  1[or  its  equivalent  in  Indian  rupees]  for  expenditure  as  may  be  required  for 
inspection or visit of the manufacturing premises or drugs, by the licensing authority 
or  by  any  other  persons  to  whom  powers  have  been  delegated in  this  behalf  by  the 
licensing authority under Rule 22. 

(6) The applicant shall be liable for the payment of testing fees directly to a testing 
laboratory  approved  by the Central Government  in India  or   abroad,  as   may   be 
required for examination, tests and analysis of drug. 

(7) A fee of three hundred US dollars 1[or its equivalent in Indian rupees] shall be 
paid  for  a  duplicate  copy  of  the  Registration  Certificate,  if  the  original  is  defaced, 
damaged or lost. 

(8) No Registration Certificate shall be required under these Rules in respect of an 
inactive  bulk  substance  to  be  used  for  a  drug  formulation,  with  or  without 
pharmacopoeial conformity.] 

1. Ins. by G.S.R. 35(E), dt. 20.1.2005.

45 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

25. Licences for import of drugs manufactured by one manufacturer.– (1) A single 
application may be made, and a single licence may be issued, in respect of the import 
of more than one drug or class of drugs manufactured by the same manufacturer: 

1[Provided that  the  drugs or  classes of  drugs  are  manufactured at  one  factory  or 

more than one factory functioning conjointly as a single manufacturing unit: 

Provided further that if a single manufacturer has two or more factories situated in 
different places manufacturing the same or different drugs a separate licence shall be 
required in respect of the drugs manufactured by each such factory.] 

2[*  *   *  * *] 

3[25A.  Condition to  be  satisfied  before  a  licence  in  Form  10  or  Form  10-A  is
(1) A licence in Form 10 or in Form 10-A shall be granted by the licensing

granted. 
authority having regard to– 

(i)  the  premises,  where  the  imported  substances  will  be  stocked,  are 
equipped with proper storage accommodation for preserving the properties of the 
drugs to which the licence applies; and 

(ii)  the  occupation,  trade  or  business  ordinarily  carried  out  by  the 

applicant: 

Provided that the licensing authority may refuse to grant a licence in Form 10-A 

in respect of any applicant where he is satisfied,-- 

(a) that the applicant has not complied with the provisions of the Act or 

these rules; or 

(b) that by reasons of— 

4[(i) his conviction under the Act or these Rules or the Narcotic Drugs 
and  Psychotropic  Substances  Act,  1985  (61  of  1985)  or  the  rules  made 
thereunder;] 

(ii) previous suspension or cancellation of the licence granted to him; 

he is not a fit person to whom licence shall be granted. 

(2) Any person who is aggrieved by the order passed by the licensing authority 
under  this  Rule  may,  within  thirty  days  of  the  receipt  of  the  order,  appeal  to  the 
Central  Government  and  the  Central  Government  may  after  such  enquiry  into  the 
matter  as  it  considers  necessary  and  after  giving  the  appellant  an  opportunity  for 
making a representation in the matter, make such orders in relation thereto as it thinks 
fit.] 

1.  Ins. by Notfn. No. F. 1-19/48-D, dt. 27-10-1949. 
2.  Omitted Notfn. No.F. 1-16/57-D, dt. 15-6-1957. 
3.  Subs. by G.S.R 462(E), dt. 22-6-1982. Earlier Ins. by Notfn. No. F. 1-9/52-D. dt. 3-11-1958. 
4.  Subs. by G.S.R 604 (E), dt. 24-8-2001. 

46 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[25B.    Registration    Certificate    for    import    of   drugs    manufactured    by   one 
manufacturer.--(1)  A  single  application  may  be  made,  and  a  single  Registration 
Certificate in Form 41 may be issued in respect of the import of more than one drug 
or class of drugs, manufactured by the same manufacturer: 

Provided  that  the  drug  or  classes  of  drugs,  are  manufactured  at  one  factory  or 

more than one factory functioning conjointly as a single manufacturing unit: 

Provided further that if a single manufacturer has two or more factories situated in 
different  places  manufacturing  the  same  or  different  drugs,  separate  Registration 
Certificates  shall  be  required  in  respect  of  the  drugs  manufactured  by  each  such 
factory.] 

26.  Conditions  of  import  licence. 

An  import  licence  shall  be  subject  to  the

following conditions: 

(i) the manufacturer shall at all times observe the undertaking given by him 

or on his behalf in Form 9; 

(ii)  the  licensee   shall  allow   any   Inspector   authorised  by  the  licensing 
authority in that behalf to enter with or without notice any premises where the 
imported  substance  is  stocked,  to  inspect  the  means,  if  any,  employed  for 
testing the substance and to take samples; 

(iii)  the  licensee  shall  on  request  furnish  to  the  licensing  authority  from 
every  batch  of  each  substance  or  from  such  batch  or  batches  as  the  licensing 
authority  may  from  time  to  time  specify  a  sample  of  such  amount  as  the 
licensing authority  may  consider  adequate for  any  examination required to  be 
made, and the licensee shall, if so required, furnish full protocols of the tests, if 
any, which have been applied; 

(iv) if the licensing authority so directs the licensee shall not sell or offer 
for  sale  any  batch  in  respect  of  which  a  sample  is  or  protocols  are  furnished 
under the  last  preceding sub-rule until  a  certificate  authorising the  sale  of  the 
batch has been issued to him by or on behalf of the licensing authority; 

(v) the licensee shall, on being informed by the licensing authority that any 
part of any batch of the substance has been found by the licensing authority not 
to  conform  with  the  standards  of  strength,  quality  and  purity  prescribed  by 
Chapter III  of the Act, or the rules thereunder and on being directed so to do, 
withdraw  the  remainder  of  that  batch  from  sale  and,  so  far  as  may  in  the 
particular  circumstances  of  the  case  be  practicable,  recall  the  issues  already 
made from that batch; 

(vi) the licensee shall maintain a  record of all sales by  him of substances for 
the  import  of  which  a  licence  is  required,  showing  particulars  of  the  substance 
and  of  the  person  to  whom  sold  and  such  further  particulars,  if  any,  as  the 
licensing authority may specify and such record shall be open to the inspection of 
any Inspector authorised in that behalf by the licensing authority: 

1.  Ins. by G.S.R. No. 604(E), dt. 24-8-2001.

47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[Provided that in respect of the sale or distribution of drugs specified in    Schedule 
X,  the  licensee  shall  maintain  a  separate  record  or  register  showing  the  following 
particulars, namely:  

1. Name of the Drug, 

2. Batch number, 

3. Name and address of the manufacturer, 

4. Date of transaction, 

5. Opening stock on the business day, 

6. Quantity of drug received, if any, and the source from which received, 

7. Name of the purchaser, his address and licence number, 

8. Balance quantity of drug at the end of the business day, 

9. Signature of the person under whose supervision the drugs have been 

supplied.] 

(vii)   the   licensee   shall   comply   with   such   further  requirements,  if   any, 
applicable  to  the  holders  of  import  licenses,  as  may  be  specified  in  any  rules, 
subsequently  made  under  Chapter  III  of  the  Act  and  of  which  the  licensing 
authority has given to him not less than four months‘ notice. 

27. Grant of import licence.  On receipt of an application for an import licence
in the form and manner prescribed in Rule 24, the licensing authority shall, on being 
satisfied  that,  if  granted,  the  conditions  of  the  licence  will  be  observed,  issue  an 
import licence in Form 10 1[or From 10A, as the case may be]. 

2[27A  Grant  of  Registration  Certificate. 

(1)  On  receipt  of  an  application  for

Registration Certificate in the Form and manner specified in Rule 24A, the licensing 
authority shall, on  being satisfied, that, if  granted, the  conditions of  the  Registration 
Certificate will be observed, issue a Registration Certificate in Form 41: 

Provided    further    that   if    the    application    is    complete    in    all    respects    and 
informations specified in Schedules D-I and D-II are in order, the licensing authority 
shall,  within  nine  months  from  the  date  of  receipt  of  an  application,  issue  such 
Registration  Certificate,  and  in  exceptional  circumstances  and  for  reasons  to  be 
recorded in writing, the Registration Certificate may  be  issued within such extended 
period, not exceeding three months, as the licensing authority may deem fit. 

(2) If the applicant does not receive the Registration Certificate within the period 
as specified in the proviso to sub-rule (1), he may appeal to the Central Government 
and  the  Central  Government may  after  such  enquiry  into  the  matter,  as  it  considers 
necessary, may pass such orders in relation thereto as it thinks fit.] 

1.  Ins. by G.S.R 462 (E), dt. 22-6-1982. 
2.  Ins. by G.S.R 604 (E), dt. 24-8-2001.

48 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[28.  Duration  of  import  licence.  A  licence  unless,  it  is  sooner  suspended  or

cancelled, shall be 2[valid for a period of three years from the date of its issue:] 

Provided  that  if  application  for  a  fresh  licence  is  made  three  months  before  the 
expiry of the existing licence the current licence shall be deemed to continue in force 
until orders are passed on the application.] 

3[28A. Duration of Registration Certificate.—- A Registration Certificate, unless, 
it is sooner suspended or cancelled, shall be valid for a period of three years from the 
date of its issue: 

Provided that  if  the  application for  a  fresh  Registration Certificate  is  made  nine 
months  before   the   expiry   of   the   existing  certificate,  the   current  Registration 
Certificate  shall  be  deemed  to  continue  in  force  until  orders  are  passed  on  the 
application.] 

4[29.  Suspension  and cancellation  of import  licence. 

 If  the  manufacturer  or
licensee fails to comply with any of the conditions of an import licence, the licensing 
authority may after giving the manufacturer or licensee an opportunity to show cause 
why  such  an  order  should  not  be  passed,  by  an  order  in  writing  stating  the  reasons 
therefor,  suspend  or  cancel  it  for  such  period  as  it  thinks  fit,  either  wholly  or  in 
respect of some of the substances to which it relates: 

Provided  that  a  person,  who  is  aggrieved  by  the  order  passed  by  the  licensing 
authority under this rule may, within thirty days of the receipt of the order, appeal to 
the Central Government, and the Central Government may, after such enquiry into the 
matter  as  it  considers  necessary  and  after  giving  the  appellant  an  opportunity  for 
representing his views in  the  matter, pass such orders in relation thereto as it  thinks 
fit.] 

3[29A.  Suspension  and  cancellation  of  Registration  Certificate.  —If 
the 
manufacturer  fails  to   comply  with   any   of   the  conditions  of   the   Registration 
Certificate, the licensing authority may after giving him an opportunity to show cause 
why  such  an  order  should  not  be  passed,  by  an  order  in  writing  stating  the  reasons 
therefor, suspend or cancel the Registration Certificate for such period as it thinks fit 
either wholly or in respect of some of the substances to which it relates: 

Provided  that  a  person,  who  is  aggrieved  by  the  order  passed  by  the  licensing 
authority under this rule may, within thirty days of the receipt of the order, appeal to 
the Central Government, and the Central Government may, after such enquiry into the 
matter  as  it  considers  necessary  and  after  giving  the  appellant  an  opportunity  for 
representing his views in  the  matter, pass such orders in relation thereto as it  thinks 
fit.] 

1.  Amended by Notfn. No. F. 1-10/62-D, dt. 19-4-1964. 
2.  Subs. by G.S.R 604 (E), dt. 24-8-2001. 
3.  Ins. by G.S.R 604 (E), dt. 24-8-2001. 
4.  Subs. by G.S.R 604 (E), dt. 24-8-2001.

49 

 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

30. Prohibition of import after expiry of potency. —No biological or other special 
product specified in Schedule C or C (I) shall be imported after the date shown on the 
label,  wrapper  or  container  of  the  drug  as  the  date  up  to  which  the  drug  may  be 
expected to  retain  a  potency  not  less  than,  or  not  to  acquire  a  toxicity  greater  than, 
that required, or as the case may be, permitted by the prescribed test. 

1[* * *   *  *] 
2[30AA.  Import  of  new  Homoeopathic  medicine.—(1)  No  new  Homoeopathic 
medicine  shall  be  imported  except  under  and  in  accordance  with  the  permission  in 
writing of the Licensing Authority. 

(2) The importer of a New Homoeopathic medicine when applying for permission 
shall produce before the Licensing Authority such documentary and other evidence as 
may be required by  the Licensing Authority for assessing the therapeutic efficacy of 
the medicine including the minimum provings carried out with it.] 

3[Explanation.  —For  the  purpose  of  this  rule,  ‗New  Homoeopathic  Medicine‘ 

means— 

(i) a Homoeopathic medicine which is not specified in the Homoeopathic 
Pharmacopoeia of India or United States of America or of the United Kingdom 
or the German Homoeopathic Pharmacopoeia; or 

(ii)  which  is  not  recognized  in  authoritative  Homoeopathic  literature  as 

efficacious under the conditions recommended; or 

(iii)  a  combination  of  Homoeopathic  medicines  containing  one  or  more 
medicines which are not specified in any of the Pharmacopoeias referred to in 
clause (i) as Homoeopathic medicines and also not recognized in authoritative 
Homoeopathic  literature  as  efficacious  under  the  conditions  recommended.]

4[30B. Prohibition of import of certain drugs. 

No drug, the manufacture, sale

or distribution of which is prohibited in the country of origin, shall be imported under 
the same name or under any other name except for the purpose of examination, test or 
analysis.] 

5[31.  Standard for  certain imported drugs.—No drug shall be  imported unless it 
complies  with  the  standard  of  strength,  quality  and  purity,  if  any,  and  the  test 
prescribed in the Rules shall be applicable for determining whether any such imported 
drug complies with the said standard: 

Provided  that  the  drugs  intended  for  veterinary  use,  the  standards  of  strength, 
quality  and  purity,  if  any,  shall  be  those that  are  specified in  Schedule F(1)  and  the 
test prescribed in that Schedule shall be applicable for determining whether any such 
imported drug complies with the said standards and where no standards are specified 
in  Schedule F(1)  for  any  veterinary drug, the  standards for  such  drug  shall  be  those 
specified  in  the  current  edition,  for  the  time  being  in  force,  of  the  British 
Pharmacopoeia Veterinary: 

1. Rule  30A  omitted  by  G.S.R.944  (E),  dt. 21-9-1988. Earlier rules  30A    and  30AA  ins.  by  Notfn.  F.  1-
30/48-G,  Dt.  14.4.1952. 
 2.  Ins. by notification No. F 1-30/48, dt. 14-01-1952. 
3.  Subs. G.S.R. 680 (E) ,dt. 5-12-1980. 
4.  Ins. by Notfn. No. F. 1-45 4-1-1951. 
5.  Subs. G.S.R. 604 (E), dt. 24-8-2001.

50 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

Provided further that the licensing authority shall not allow the import of any drug 

having less than sixty per cent residual shelf-life period as on the date of import: 

Provided also that in exceptional cases the licensing authority may, for reasons to 
be  recorded  in  writing,  may  allow,  the  import  of  any  drug  having  lesser  shelf-life 
period, but before the date of expiry as declared on the container of the drug.] 

1[32. Packing and labelling of imported drugs.  No drug shall be imported unless
it   is packed and labelled in conformity with the Rules in Parts IX and X 2[* * *] and 
further  conform to  the  standards  laid  down  in  Part  XII  provided  that  in  the  case  of 
drugs intended for veterinary use, the packing and labelling shall conform to the rules 
in Parts IX and X and Schedule F(1)]. 

3[32A  Packing  and  Labelling  of  Homoeopathic  medicine.  No  Homoeopathic
medicine  shall  be  imported unless it  is  packed  and  labelled in  conformity  with  the 
rules in Part IX-A.] 

33. Import of drugs for examination, test or analysis  Small quantities of drugs
the  import  of  which  is  otherwise  prohibited  under  section  10  of  the  Act  may  be 
imported  for  the  purpose  of  examination,  test  or  analysis  subject  to  the  following 
conditions: 

(a)   No  drug  shall  be imported for  such  purpose except under a  licence in 

Form 11; 

(b)      the  licensee  shall  use  the  substances  imported  under  the  licence 
exclusively for purposes of examination, test or analysis and shall carry on such 
examination, test or analysis in the place specified in the licence, or in such other 
places as the licensing authority may from time to time authorise; 

(c)  the licensee shall allow any Inspector authorized by the licensing authority 
in this behalf to enter, with or without prior notice, the premises where the substances 
are  kept,  and  to  inspect  the  premises,  and  investigate  the  manner  in  which  the 
substances are being used and to take samples thereof; 

(d)    the  licensee  shall  keep  a  record  of,  and  shall  report  to  the  licensing 
authority,  the  substances  imported  under  the  licence,  together  with  the  quantities 
imported, the date of importation and the name of the manufacturer; 

(e)  the licensee shall comply with such further requirements, if any, applicable 
to  the  holders  of  licences  for  examination, test  or  analysis as  may  be  specified in 
any  rules  subsequently  made  under  Chapter  III  of  the  Act  and  of  which  the 
licensing authority has given to him not less than one month‘s notice. 

1.  Subs. by Notfn. No. F. 1-6/62-D (SO 2889), dt. 2-7-1969. 
2.  Certain words omitted  by G.S.R. 661(E), dt. 3-7-1992. 
3.  Ins. by S. O. No. 2139, dt. 5-6-1972.

51 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[33A  Import  of  drugs  by  a  Government  Hospital  or  Autonomous  Medical 
Institution for the treatment of patients.—Small quantities of new drug, as defined in 
Rule 122-E, the import of which is otherwise prohibited under section 10 of the Act, 
may be imported for treatment of patients suffering from life threatening diseases, or 
diseases causing serious permanent disability, or  such disease requiring therapies for 
unmet  medical  needs,  by  a  Medical  Officer  of  a  Government  Hospital  or  an 
Autonomous Medical Institution providing tertiary care, duly certified by the Medical 
Superintendent  of  the  Government  Hospital,  or  Head  of  the  Autonomous  Medical 
Institution, subject to the following conditions, namely:- 

(a) no new drug shall be imported for the said purpose except under a licence 
in Form 11-A, and the said drug has been approved for marketing in the country 
of origin; 

(b) the licensee shall use the substances or drugs imported under the licence 
exclusively for the purpose of treatment of patients suffering from life threatening 
diseases,  or  diseases  causing  serious  permanent  disability,  or  such  diseases 
requiring  therapies  for  unmet  medical  needs,  under  the  supervision  of  its  own 
Medical Officers at the place, specified in the licence or at such other places, as 
the licensing authority, may  from time to time authorise; 

(c) the licensee shall allow an Inspector authorised by the licensing authority 
in  this  behalf  to  enter,  with  or  without  prior  notice,  the  premises  where  the 
substances or drugs are stocked, and to inspect the premises and relevant records 
and investigate the manner   in which the substances or drugs are being used and 
to take, if necessary, samples   thereof ; 

(d) the licensee shall  keep a  record of,  and shall  submit the  said  report half 
yearly  to  the      licensing  authority,  the  substances  or  drugs  imported  under  the 
licence, together with the quantities imported and issued to the patients, the date 
of importation, the name of the manufacturer, the name and address of the patient 
for whom the drug is prescribed and the name of disease; 

(e) the licensee shall comply with such other requirements, if any, applicable 
to the holders of import licences for import of new drugs for treatment of patients 
by  Government  Hospitals,  as  may  be  specified  from  time  to  time  in  any  rule 
subsequently  made  under      Chapter  III  of  the  Act  and  of  which  the  licensing 
authority has given to him not less than one month‘s notice; 

(f)  the  drug  shall  be  stocked  under  proper  storage  conditions  and  shall  be 

dispensed under the supervision of a registered pharmacist; 

(g) the quantity of any single drug so imported shall not exceed 100 average 

dosages per patient: 

Provided that  the licensing authority may, in exceptional circumstances, sanction 

the import of drug of a larger quantity.] 

34.  Application for licence for examination, test or analysis. 

(1) An application
for a licence for examination, test or analysis shall be made in Form 12 and shall be 
made or  countersigned by  the  head of  the  institution in  which, or  by  a  proprietor or 
director  of  the  company  or  firm  by  which  the  examination, test  or  analysis  will  be 
conducted. 

1.  Ins. by  G.S.R 604 (E), dt. 24-8-2001.

52 

 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(2) The licensing authority may require such further particulars to be supplied as 

he may consider necessary. 

1[(3) Every application in Form 12 shall be accompanied by a fee of one hundred 

rupees for a single drug and an additional fee of fifty rupees for each additional drug. 

(4)  The  fees  shall  be  paid  through  a  challan  in  the  Bank  of  Baroda,  Kasturba 
Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, 
or any other Bank, as notified, from time  to  time,  by the Central Government, to be 
credited  under  the  Head  of  Account  0210-Medical  and  Public  Health,  04-  Public 
Health, 104- Fees and Fines.] 

2[34A.  Application  for  licence  to  import  small  quantities  of  new  drugs  by  a 
Government  Hospital   or   Autonomous  Medical   Institution  for   the   treatment   of
patients.  (1) An application  for an import licence for small quantities of a new drug,
as defined in Rule 122-E for the purpose of treatment of patients suffering from life 
threatening  diseases,  or  diseases  causing  serious  permanent  disability,  or  such 
diseases requiring therapies for unmet medical needs, shall be made in Form 12-AA, 
by a Medical Officer of the Government Hospital or Autonomous Medical Institution, 
which shall be certified by the Medical Superintendent of the Government Hospital or 
Head of the Autonomous Medical Institution, as the case may be. 

(2) The licensing authority may require such further particulars to be supplied, as 

he may consider necessary. 

(3)  Every  application  in  Form  12-AA  shall  be  accompanied  by  a  fee  of  one 
hundred  rupees  for  a  single  drug  and  an  additional  fee  of  fifty  rupees  for  each 
additional drug. 

(4)  The  fees  shall  be  paid  through  a  challan  in  the  Bank  of  Baroda,  Kasturba 
Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, 
or any other Bank, as notified, from time  to  time,  by the Central Government, to be 
credited  under  the  Head  of  Account  0210-  Medical  and  Public  Health,  04-  Public 
Health, 104- Fees and Fine.] 

35. Cancellation of licence  for examination, test  or analysis.  (1)   A  licence for
examination, test or analysis may be cancelled by the licensing authority for breach of 
any of the conditions subject to which the licence was issued. 

(2)  A  licensee  whose  licence  has  been  cancelled  may  appeal  to  the  Central 

Government within three months of the date of the order. 

1.  Subs. by G.S.R 604 (E), dt. 24-8-2001. 
2.  Ins. by  G.S.R 604 (E), dt. 24-8-2001.

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 Drugs and Cosmetics Rules 1945 

1[35A.  Cancellation  of  licence  for  import  of  small  quantities  of  new  drugs.  (1)  A
licence  for  import  of  small  quantities  of  a  new  drug,  defined  in  Rule122E,  for  the 
purpose  of  the  treatment  of  patients  suffering  from  life  threatening  diseases,  or  diseases 
causing  serious  permanent  disability,  or  such  diseases  requiring  therapies  for  unmet 
medical needs, by a Government Hospital or an Autonomous Medical Institution may be 
cancelled by the licensing authority  for breach of any of the conditions subject to which 
the licence was issued or   for contravention of any of the provisions of the Act and rules 
made thereunder. 

(2)  A  licensee  whose  licence  has  been  cancelled  may  appeal  to  the  Central 
Government within three months from the date of the receipt of the order, and the Central 
Government  may  after  such  enquiry  into  the  matter,  as  it  considers  necessary  and  after 
giving  the  appellant  an  opportunity  for  representing  his  views,  may  pass  such  orders  in 
relation thereto, as it thinks fit.] 

36. Import of drugs for personal use.  Small quantities of drugs, the import of which
is  otherwise  prohibited  under  section  10  of  the  Act,  may  be  imported  for  personal  use 
subject to the following conditions: 

(i) the drugs shall form part of a passenger‘s bona fide baggage and shall be the 

property of, and be intended for, the exclusive personal use of the passenger; 

(ii) the drugs shall be declared to the Customs authorities if they so direct; 

(iii)  the  quantity  of  any  single drug  so  imported  shall  not  exceed one hundred 

average doses : 

Provided  that  the  licensing  authority  may  in  an  exceptional  case  in  any  individual 

case sanction the import of a larger quantity: 

2[Provided  further  that  any  drug,  imported  for  personal  use  but  not  forming  part  of 
bona  fide  personal  baggage,  may  be  allowed  to  be  imported  subject  to  the  following 
conditions, namely: 

(i)    the  licensing  authority,  on  an  application  made  to  it  in  Form  12A  is 

satisfied that the drug is for bona fide personal use; 

(ii)    the  quantity  to  be  imported  is  reasonable  in  the  opinion  of  the  licensing 
authority  and  is  covered  by  prescription  from  a  registered  medical  practitioner  ; 
and 

(iii)   the licensing authority grants a permit in respect of the said drug in Form 

12B.] 

3[37.  Packing  of  patent  or  proprietary  medicine.  —Patent  or  proprietary 

medicines shall be imported in containers intended for retail sale: 

4[Provided  that  such  medicines  may  be  imported  in  bulk  containers  by  any 
person  who  holds  a  licence  to  manufacture,  if  such  person  has  obtained  permission  in 
writing to import such medicines from the licensing authority at least three  months prior 
to the date of  import  and  the  imports  are  made  within  a  period  of  twelve  months  from 
the  date  of issue of such permission].] 

38. Statement to accompany imported drugs.  All consignments of drugs sought to be
imported  shall  be  accompanied  by  an  invoice  or  other statement  showing  the  name and 
address of the manufacturer and the name and quantities of the drugs.

39. Documents to be supplied to the Customs Collector.  Before drugs for the import
of which a licence is not required are imported a declaration signed by or on behalf of the 
manufacturer or by or on behalf of the importer that the drugs comply with the provisions 
of  Chapter  III  of  the  Drugs  and  Cosmetics  Act,  1940  and  the  Rules  thereunder  shall  be 
supplied to the Customs Collector. 

1.  Ins. by  G.S.R 604 (E), dt. 24-8-2001. 
2.  Ins. by Notfn. No.F-1-36/54-D.S., (SRO 560), dt. 3-3-1955. 
3.  Ins. by Notfn. No.F-1-3/51-D.S., (SRO 3262), dt. 15-10-1954. 
4.  Ins. by Notfn. No.F-1-45/58-D, (SO 115), dt. 4-1-1961.

54 

 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[40. Procedure for the import of drugs.   (1)  If the Customs Collector has reason
to doubt whether any drugs comply with the provisions of Chapter III of the Act and 
Rules thereunder he may, and if requested by an officer appointed for this purpose by 
the  Central  Government  shall,  take  samples  of  any  drugs  in  the  consignment  and 
forward  them  to  the  Director  of  the  laboratory  appointed  for  this  purpose  by  the 
Central Government and may detain the drugs in  the consignment of which samples 
have  been  taken  until  the  report  of  the  Director  of  the  said  laboratory  or  any  other 
officer  empowered  by  him  on  this  behalf,  subject  to  the  approval  of  the  Central 
Government, on such samples is received: 

Provided that if the importer gives an undertaking in writing not to dispose of the 
drugs without the consent of the Customs Collector and to return the consignment or 
such  portion thereof as  may  be  required, the  Customs Collector shall  make  over  the 
consignment to the importer. 

(2) If an importer who has given an undertaking under the proviso to sub-rule (1) 
is required by the Customs Collector to return the consignment or any portion thereof 
he  shall  return  the  consignment or  portion  thereof  within  ten  days  of  receipt  of  the 
notice.] 

2[41. (1) If the Director of the laboratory appointed for the purpose by the Central 
Government  or  any  other  officer  empowered  by  him  on  this  behalf,  subject  to  the 
approval  of  the  Central  Government,  reports  to  the  Customs  Collector  that  the 
samples  of  any  drug  in  a  consignment  are  not  of  standard  quality,  or  that  the  drug 
contravenes in any other respect the provisions of Chapter III of the Act or the Rules 
thereunder  and  that  the  contravention  is  such  that  it  cannot  be  remedied  by  the 
importer,  the  Customs  Collector  shall  communicate  the  report  forthwith  to  the 
importer  who  shall,  within  two  months  of  his  receiving  the  communication  either 
export  all  the  drugs  of  that  description in  the  consignment, to  the  country  in  which 
they were manufactured or forfeit them to the Central Government which shall cause 
them to be destroyed : 

Provided that the importer may within fifteen days of receipt of the report make a 
representation against the report to the Customs Collector, and the Customs Collector 
shall forward the representation with a further sample to the licensing authority, who 
after  obtaining,  if  necessary,  the  report  of  the  Director  of  the  Central  Drugs 
Laboratory, shall pass orders thereon which shall be final. 

3[(2)  If  the  Director  of  the  laboratory  appointed  for  the  purpose  by  the  Central 
Government  or  any  other  officer  empowered  by  him  on  this  behalf,  subject  to  the 
approval of the Central Government reports to the Customs Collector that the samples 
of any drug contravene in any respect the provisions of Chapter III of the Act or the 
Rules  thereunder  and  that  the  contravention  is  such  that  it  can  be  remedied  by  the 
importer,  the  Customs  Collector  shall  communicate  the  report  forthwith  to  the 
importer and  permit  him  to  import the  drug  on  his  giving  an  undertaking in  writing 
not  to  dispose  of  the  drug  without  the  permission  of  the  officer  authorised  in  this 
behalf by the Central Government.]] 

4[*  *    *    *   *] 

1. Subs. by Notifn. 1-99/52-D.S., dated 3-11-1953. 
2.  Subs. by Notfn. No. F. 7-7/47-D, dt. 5-1-1954. 
3.  Ins. by Notfn. No. 7-11/47-D, dt. 5-10-1951. 
4.  Rule 42 omitted  by Notfn. No. F. 1-9/52-DS., dt. 3-11-1953.

55 

 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

43.  The  drugs  specified  in  Schedule  D  shall  be  exempt  from  the  provisions  of 
Chapter III of the Act and of the Rules made thereunder to the extent, and subject to 
the conditions specified in that Schedule. 

1[43A. No drug shall be imported into India except through one of the following 

places, namely: 

Freozepore Cantonment and Amritsar Railway Stations: 

In respect of drugs imported by rail across the frontier with Pakistan. 

Ranaghat, Bongaon and Mohiassan Railways Stations: 

In respect of drugs imported by rail across the frontier with Bangladesh. 

5[Petrapole Road in West Bengal, Sutarkandi in Assam, Old Raghna Bazar and Agartala in 
Tripura :  

In respect of drugs imported by Road from Bangladesh;] 

2[Raxaul:  
In respect of drugs imported by road and railway lines connecting Raxaul in India 
and Birganj in Nepal;] 

4[Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla and Inland Container 
Depots at Tuglakabad and Patparganj in Delhi and Tuticorin  in Tamil Nadu and 
Marmugao port in Goa and Visakhapatnam in Andhra Pradesh:  
In respect of drugs imported by sea into India; 

Chennai, Kolkata, Mumbai, Delhi,Ahmedabad, Hyderabad, Goa, Bengaluru and 
Visakhapatnam:  
in respect of drugs imported by air into India.] 

4[43-B.  Drugs,  consignments  of  which  are  in  transit  through  India  to  foreign 
countries and which shall not be sold or distributed in  India shall be exempted from 
the requirements of  Chapter III  of  the  Drugs and  Cosmetics Act, 1940 (23 of  1940) 
and the Rules made thereunder: 

Provided that if the Government of the countries to which the drugs are consigned 
regulate their import by the grant of import licences, the importer shall at the time of 
import into India, produce such import licences.] 

1.  Subs. by G.S.R 478 (E), dt. 6-8-1981. Earlier Ins. by Notfn No. F.7/7/47-D. dt. 5-1-1954. 
2.  Ins. by G.S.R 120 (E), dt. 5-3-1998. 
3.  Sub. by G.S.R 532 (E), dt. 18-05-2016. Earlier sub. by G.S.R 575 (E), dt. 17-11-2012, G.S.R 101 (E), dt. 
18-2-2011, G.S.R 45 (E), dt. 21-1-2010,  G.S.R 504 (E), dt. 18-7-2002, G.S.R 647 (E), dt. 28-10-1998.  

          4.  Added by Notfn. No.  E. 1-60/D, (SO 1056) dt. 19-3-1964. 

5. Ins. by G.S.R. 116 (E), 24-01-2009.

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 Drugs and Cosmetics Rules 1945 

PART V 

1[GOVERNMENT ANALYSTS, INSPECTORS, LICENSING 
AUTHORITIES AND CONTROLLING AUTHORITIES] 

2[44.   Qualifications   of   Government   Analyst. 
Government Analyst under the Act shall be a person who 

A   person   appointed   as   a

(a)   is  a  graduate  in  medicine  or  science  or  pharmacy  or  Pharmaceutical 
Chemistry  of  a  3[University  established  in  India  by  law  or  has  an  equivalent 
qualification  recognized  and  notified      by  the  Central  Government  for  such 
purpose] and  has had not less than five years‘ post-graduate experience in the 
testing  of  drugs  in  a  laboratory  under  control  of  (i)  a  Government  Analyst 
appointed under the Act, or (ii) the head of an Institution or testing laboratory 
approved for  the  purpose by  the  appointing authority,  4[or  has  completed two 
years‘  training  on  testing  of  drugs,  including  items  stated  in  Schedule  C,  in 
Central Drugs Laboratory], or 

(b)   possesses  a  post-graduate degree  in  medicine  or  science  or  pharmacy 
or  Pharmaceutical   chemistry  of  a  3[University established in  India by  law  or 
has  an  equivalent  qualification  recognized  and  notified  by  the  Central 
Government for  such  purpose] or  possesses the  Associateship Diploma of  the 
Institution of Chemists (India) obtained by passing the said examination with 
‗Analysis  of  Drugs  and  Pharmaceuticals‘  as  one  of  the  subjects  and  has  had 
after  obtaining  the  said  post-graduate  degree  or  diploma  not  less  than  three 
years‘ experience in the testing of drugs in a laboratory under the control of (i) 
a  Government  Analyst  appointed  under  the  Act,  or  (ii)  the  head  of  an 
Institution  or  testing  laboratory  approved  for  the  purpose  by  the  appointing 
authority 4[or has completed training on testing of drugs, including items stated 
in Schedule C, in Central Drugs Laboratory]: 

Provided that- 

4[(i) for purpose of examination of items in Schedule C,- 

(ia)  the  persons  appointed  under  clause  (a)  or  (b)  and  having  degree  in 
Medicine,   Physiology,   Pharmacology,  Microbiology,  Pharmacy    should 
have  experience  or  training  in  testing  of  said  items  in  an  institution  or 
laboratory approved by the appointing authority for a period of not less than 
six months; 

(ib)  the  person  appointed under  clause(a)  or  (b)  but  not  having  degree  in  the 
above  subjects  should  have  experience  or  training  in  testing  of  said 
Schedule C drugs for a period of not less than three years in an institution or 
laboratory  approved  by  the  appointing  authority  or  have  completed  two 
years  training  on  testing  of  drugs  including  items  stated  in  Schedule  C  in 
Central Drugs Laboratory;] 

1.  Subs. by G.S.R 443 (E), dt. 12-4-1989. 
2.  Subs. by G.S.R. No. 1427, dt. 22-10-1977. 
3. Subs. by G.S.R. 71(E), dt 30.1.1987. 
4.  Ins.  by G.S.R 697(E) dt. 26-10-1995.

57 

 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(ii)  for a period of four years from the date on which Chapter IV of the Act 
takes effect in  the  States, persons whose training and  experience are  regarded 
by the appointing authority as affording, subject to such further training, if any, 
as may be considered necessary, a reasonable guarantee of adequate knowledge 
and competence,   may be appointed as Government Analysts.   The persons so 
appointed may, if the appointing authority so desires, continue in service after 
the expiry of the said period of four years; 

(iii) no person who is engaged directly or indirectly in any trade or business 
connected with the  manufacture of  drugs shall  be  appointed as  a  Government 
Analyst for any area: 

Provided  further  that  for  the  purpose  of  examination  of  Anti-sera,  Toxoid  and 
Vaccines and Diagnostic Antigens for Veterinary use, the person appointed shall be a 
person  who  is  a  graduate  in  Veterinary  Science,  or  general  science,  or  medicine  or 
pharmacy and  has  had  not  less  than  five  years‘  experience in  the  standardization of 
biological  products  or  person  holding  a  post-graduate degree  in  Veterinary  Science, 
or  general  science,  or  medicine  or  pharmacy  or  pharmaceutical  chemistry  with  an 
experience of not less than three years in the standardization of biological products : 

Provided  also  that  persons,  already  appointed  as  Government  Analysts  may 
continue to remain in  service, if  the  appointing authority so desires, notwithstanding 
the fact that they do not fulfil the qualifications as laid down in clause (a), clause (b) 
or the preceding proviso. 

45. Duties of Government Analysts.−(1) The Government Analyst shall cause to  
be  analysed  or  tested  such  samples  or  drugs  1[and  cosmetics]  as  may  be  sent  to 
him by Inspectors or other persons under the provisions of Chapter IV of the Act and 
shall furnish reports of the results of test or analysis in accordance with these Rules. 

(2)  A  Government  Analyst  shall  from  time  to  time  forward  to  the  Government 
reports  giving  the  result  of  analytical  work  and  research  with  a  view  to  their 
publication at the discretion of Government. 

46.  Procedure  on  receipt  of  sample.−On  receipt  of a  package  from  an  Inspector 

containing a sample for test or analysis, the Government Analyst shall compare the 
seals  on  the  packet  2[or  on  portion  of  sample  or  container] with  the  specimen 
impression received  separately  and  shall  note  the  condition  of  the  seals  on  the 
3[packet  or  on  portion  of  sample  or  container].   After  the  test  or  analysis has  been 
completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 
of the result of the test or analysis, together with full protocols of the tests or analysis 
applied: 

1.  Ins. by S.O. 2139 dt. 5-6-1972. 
2.  Ins. by G.S.R. 59(E), dt. 7-2-1995. 
3.  Subs.by G.S.R. 59(E),dt. 7-2-1995.

58 

 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[Explanation.  It  shall be  deemed to  be full  and  sufficient compliance with the
requirement of the rule in respect of the supply of ―protocols of the tests or analysis 
applied‖, if 

(1)  for  pharmacopoeial  drug,  where  the  tests  or  methods  of  analysis 
prescribed in the official pharmacopoeia are followed, references to the specific 
tests or analysis in the pharmacopoeias are given in the report; 

(2)  for  patent  or  proprietary  medicines  for  which  the  tests  and  methods 
prescribed  in  any  of  the  official  pharmacopoeias  are  applicable  and  are 
followed, references to the specific tests or analysis in the pharmacopoeias are 
given in the report; 

(3 )for patent or proprietary medicines containing pharmacopoeial drugs for 
which  the  official  tests  or  analysis  or  methods  of  assays  are  modified  and 
applied,  a  description  of  the  actual  tests  or,  as  the  case  may  be,  analysis  or 
methods of assays so applied is given in the report; 

(4) for patent or proprietary medicines for which no pharmacopoeial tests or 
methods  of  analysis  are  available  or  can  be  applied  but  for  which      tests  or 
methods  of  analysis  given  in  standard  books  or  journals  are  followed,  a 
description  of  such  tests  or  methods  of  analysis  applied  together  with  the 
reference to  the  relevant books or journals from which the tests or  methods of 
analysis have been adopted, is given in the report; 

(5)  for  those  drugs  for  which  methods  of  test  are  not  available  and  have 
been  evolved  by  the  Government  Analyst,  a  description  of  tests  applied  is 
given in the report.] 

47. Report of result of test or analysis.  An application from a purchaser for test
or analysis of a drug under section 26 of the Act shall be made in Form 14 A and the 
report of test or analysis of the drug made on such application shall be supplied to the 
applicant in Form 14B. 

48.  Fees. 

The  fees  to  be  paid  by  a  person  submitting  to  the  Government
Analyst  under  section  26  of  the  Act  for  test  or  analysis  of  a  drug  3[or  cosmetic] 
purchased by him shall be those specified in Schedule B. 

2[49.  Qualifications  of  Inspectors.  —A  person  who  is  appointed  an  Inspector 
under  the  Act  shall  be  a  person  who  has  a  degree  in  Pharmacy  or  Pharmaceutical 
Sciences  or  Medicine with  specialisation in  Clinical  Pharmacology or  Microbiology 
from a University established in India by law: 

Provided that only those Inspectors: ⎯ 

1.  Ins. by No. F. 1-60/61-D, dt. 12-7-1962 (G.S.R 984 (E), dt. 12-7-1962). 
2.  Subs. by No. G.S.R 658 (E), dt. 19-10-1993. 
3. Ins. by No. G.S.R 1140 (E), dt. 26-8-1978.

59 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(i) Who have not less than 18 months‘ experience in the manufacture of 

at least one of the substances specified in Schedule C, or 

(ii)  Who  have  not  less  than  18  months‘  experience in  testing  of  at  least 
one of the substances in Schedule C in  a laboratory approved for this purpose 
by the licensing authority, or 

(iii)  Who  have  gained  experiences  of  not  less  than  three  years  in  the 
inspection of firms manufacturing any of the substances specified in Schedule 
C during the tenure of their services as Drugs Inspectors;  

shall be authorised to inspect the manufacture of the substances mentioned in Schedule 
C:] 

1[Provided further that the requirement as to the academic qualification shall not 
apply to persons appointed as Inspectors on or before the 18th day of October, 1993.] 

2[ 49A. Qualification of a Licensing Authority.—No person shall be qualified to be a 
Licensing Authority under the Act unless:- 

(i) he is a  graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine 
with  specialization in  clinical  pharmacology  or  microbiology  from  a  University 
established in India by law; and 

(ii) he has experience in the manufacture or testing of drugs or enforcement of 

the provisions of the Act for a minimum period of five years: 

3[ Provided that the requirements as to the academic qualification shall not apply 
to  those  inspectors  and  the  Government  Analysts  who  were  holding  those  positions 
on the 12th day of April,1989.]] 

4[50.  Controlling  authority.  (1)  All  Inspectors  appointed  by  the  Central
Government shall be under the control of an officer appointed in this behalf by the 
Central Government. 

(2) All Inspectors appointed by the State Government shall be under the control 

of an officer appointed in this behalf by the State Government. 

(3) For the purposes of these rules an officer appointed by the Central Government 
under  sub-rule  (1),  or  as  the  case  may  be,  an  officer  appointed  by  the  State 
Government under sub-rule (2), shall be a controlling authority.] 

1.  Ins. by  G.S.R 552 (E), dt. 4-12-1996. 
2.  Ins. by G.S.R 443 (E), dt. 12-4-1989. 
3.  Subs. by G.S.R. 532 (E), dt. 14.8.1991. 
4.  Subs. by  S.O. 2139, dt. 5-6-1972.

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 Drugs and Cosmetics Rules 1945 

1[50A. Qualification of a Controlling Authority. 

(1) No person shall be qualified

to be a Controlling Authority under the Act unless 

(i)  he  is  a  graduate  in  Pharmacy  or  Pharmaceutical  Chemistry  or  in 
Medicine  with  specialization  in  Clinical  Pharmacology  or  Microbiology  from  a 
University established in India by law; and 

(ii) he has experience in the manufacture or testing of drugs or enforcement of 

the provisions of the Act for a minimum period of five years: 

2[Provided that the requirements as to the academic qualifications shall not apply 
to those Inspectors and the Government Analysts who were holding those positions 
on the 12th day of April, 1989.] 

51.   Duties   of   Inspectors   of   premises   licensed   for   sale. 

Subject   to   the
instructions of the controlling authority, it shall be duty of an Inspector authorized to 
inspect premises licensed for the sale of drugs 

(1) to inspect  3[not less than once a year] all establishments licensed for the 

sale of drugs within the area assigned to him; 

(2) to satisfy himself that the conditions of the licences are being observed; 

(3)  to  procure  and  send  for  test  or  analysis, if  necessary, imported packages 
which  he  has  reason  to  suspect  contain  drugs  being  sold  or  stocked  or  exhibited 
for sale in contravention of the provisions of the Act or Rules thereunder; 

(4) to investigate any complaint in writing which may be made to him; 

(5)  to  institute  prosecutions  in  respect  of  breaches  of  the  Act  and  Rules 

thereunder; 

(6) to maintain a record of all inspections made and action taken by him in the 
performance  of  his  duties,  including  the  taking  of  samples  and  the  seizure  of 
stocks, and to submit copies of such record to the controlling authority; 

(7) to make such enquiries and inspections as may be necessary to detect the 

sale of drugs in contravention of the Act; 

1.  Ins. by  G.S.R 443 (E), dt. 12-04-1989. 
2.  Subs. by G.S.R 532 (E), dt. 14-8-1991. 
3.  Subs. by G.S.R. 700 (E), dt. 28-9-2001.

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 Drugs and Cosmetics Rules 1945 

(8)  when  so  authorized by  the  State  Government, to  detain  imported packages 
which he has reason to suspect contain drugs, the import of which is prohibited. 

52.  Duties  of  Inspectors  specially  authorized  to  inspect  the  manufacture  of
1[drugs or cosmetics].  Subject to the instructions of the controlling authority it shall
be the duty of an Inspector authorized to inspect the manufacture of drugs 

(1)  to  inspect  2[not  less  than  once  a  year],  all  premises  licensed  for 
manufacture of  1[drugs  or  cosmetics]  within  the  area  allotted  to  him  to  satisfy 
himself that  the  conditions of  the  licence  and  provisions of  the  Act  and  Rules 
thereunder are being observed; 

(2)  in the case of establishments licensed to manufacture products specified 
in Schedules C and C(1) to inspect the plant and the process of manufacture, the 
means  employed  for  standardizing  and  testing  the  2[drugs  or  cosmetics],  the 
methods and place of storage, the  technical qualifications of the staff employed 
and all  details of location, construction and administration of the establishment 
likely to affect the potency or purity of the product; 

(3)  to  send  forthwith  to     the  controlling  authority  after  each  inspection  a 
detailed report indicating the conditions of the licence and provisions of the Act 
and   rules   thereunder  which   are   being   observed  and   the   conditions  and 
provisions, if any, which are not being observed; 

(4)  to  take  samples  of  the   1[drugs  or  cosmetics]  manufactured  on  the 

premises and send them for test or analysis in accordance with these Rules; 

(5)  to  institute  prosecutions  in  respect  of  breaches  of  the  Act  and  Rules 

thereunder. 

53. Prohibition of disclosure of information.  Except for the purposes of official
business  or  when  required  by  a  Court  of  Law,  an  Inspector  shall  not,  without  the 
sanction  in  writing  of  his  official  superior,  disclose  to  any  person  any  information 
acquired by him in the course of his official duties. 

54. Form of order not to dispose of stock.  An order in writing by an Inspector
under clause  (c)  of  section 22  of  the  Act requiring   a  person not  to  dispose of  any 
stock in his possession shall be in Form 15. 

1.  Subs. by G.S.R 504 (E), dt. 18-7-2002. 
2.  Subs. by G.S.R 700 (E), dt. 28-9-2001.

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1[54A. Prohibition of sale.  No person in possession of a drug 2[or cosmetic] in
respect of which an Inspector has made an order under clause (c) of sub-section (1) of 
section 22 of the Act shall in contravention of that order sell or otherwise dispose of 
any stock of such drug 2[or cosmetic]. 

3[55.  Forms  of  receipts  for  seized  drug,  cosmetic,  record  register,  document  or 
any  other  material  object.--  A  receipt  by  an  Inspector  for  the  stock  of  any  drug  or 
cosmetic or for any record, register, document or any other material object seized by 
him under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act shall be 
in Form 16.] 

4[55A.  Manner  of  certifying  copies  of  seized  documents.—The  Drugs  Inspector 
shall return the documents , seized by him under clause (cc) or produced before him 
under  clause  (cca),  of  sub-section  (1)  of  section  22  of  the  Act,  within  a  period  of 
twenty days of the date of such seizure or production, to the person from whom they 
have  seized  or,  as  the  case  may  be,  the  person  who  produced  them,  after  copies 
thereof of extracts therefrom have been signed by the concerned Drug Inspector and 
the person from whom they have seized , or, as the case may be , who produced such 
records.] 

56. Form of intimation of purpose of taking samples.  When an Inspector takes a
sample of a drug for the purpose of test or analysis, he shall intimate such purpose in 
writing in Form 17 to the person from whom he takes it. 

5[56A.  Form  or  receipt  for  samples  of  drugs  where  fair  price  tendered  is 
refused.—Where the fair price, for the samples of drugs taken for the purpose of test 
or  analysis,  tendered  under  sub-section  (1)  of  section  23  has  been  refused,  the 
Inspector  shall  tender  a  receipt  therefor  to  the  person  from  whom  the  said  samples 
have been taken as specified in Form 17A.] 

57. Procedure for despatch of sample to Government Analyst.  (1) The portion of
sample  or  the  container  sent  by  an  Inspector to  the  Government Analyst  for  test  or 
analysis under sub-section (4) of section 23 of the Act shall be sent by registered post 
or by hand in a sealed packet, enclosed together with a memorandum in Form 18, in 
an outer cover addressed to the Government Analyst. 

(2)  A  copy  of  the  memorandum and  a  specimen  impression of  the  seal  used  to 
seal the packet shall be sent to the Government Analyst separately by registered post 
or by hand. 

1.  Ins. by No. F. 1-19/59-D, dt. 13-6-1961. 
2.  Ins. by G.S.R 850(E), dt. 07-12-1994. 
3.  Subs. by G.S.R. No. 926 dt. 16-7-1977. 
4.  Ins. by G.S.R 89 (E), dt. 16-2-1985. 
5.  Ins. by G.S.R 292 (E), dt. 29-5-1997.

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1[58. Confiscation of drugs, implements, machinery etc.  (1) Where any person has

been convicted for contravening any of the provisions of Chapter IV of the Act or any 

Rule made thereunder, the stock of the drug in respect of which the contravention has 

been made shall be liable to confiscation. 

(2)  Where  any  person  has  been  convicted  for  the  manufacture  of  any  drug 

deemed to be misbranded under clause (a), clause (b), clause (c), clause (d), clause (f) 

or  clause  (g)  of  section  17  of  the  Act,  or  adulterated drug  under  section  17B  of  the 

Act,  or  for  manufacture for  sale,  or  stocking  or  exhibiting for  sale  or  distribution of 

any drug without a valid licence as required under clause (c) of section 18 of the Act, 

any  implements or  machinery used in  such  manufacture, sale  or  distribution and  any 

receptacle,  packages,  or  coverings  in  which  such  drug  is  contained  and  the  animals, 

vehicles, vessels or other conveyances used in carrying such drug shall also be liable 

to confiscation.] 

2[58A. Procedure for  disposal of  confiscated drugs. 

(1)   The Court shall refer

the confiscated drugs to the Inspector concerned for report as to whether they are of 

standard quality or contravene the provisions of the Act or the Rules in any respect. 

(2)  If  the  Inspector,  on  the  basis  of  Government  Analyst‘s  report  finds  the 

confiscated drugs to be not of standard quality or to contravene any of the provisions 

of the Act or the Rules made thereunder, he shall report to the Court accordingly. The 

Court  shall thereupon order  the  destruction of  the  drugs.   The  destruction shall  take 

place under the supervision of the Inspector in the presence of such authority, if any, 

as may be specified by the Court. 

(3) If the Inspector finds that the confiscated drugs are of standard quality and do 

not contravene the provisions of the Act or the Rules made thereunder, he shall report 

to the Court accordingly.  3[The Court may then order the Inspector to give the stocks 

of  confiscated  drugs  to  hospital  or  dispensary  maintained  or  supported  by  the 

Government or by Charitable Institutions].] 

1.  Subs. by S. O. 289, dt. 3-2-1973. 
2.  Ins. by No. F. 1-9/62-D (GSR 6), dt. 2-12-1964. 
3.  Subs. by G.S.R 59 (E), dt. 7-2-1995.

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PART VI 

SALE OF DRUGS OTHER THAN  HOMOEOPATHIC MEDICINES 

59. (1) The State Government shall appoint Licensing Authorities for the purpose 

of this Part for such areas as may be specified. 

1[(2) Applications for the grant or renewal of a licence  2[to sell, stock, exhibit or 
offer for sale or distribute] drugs, other than those included in Schedule X,  3[shall be 
made in Form 19 accompanied by a fee of rupees one thousand and five hundred or 
Form 19A accompanied by a fee of rupees five hundred, as the case may be, or in the 
case of drugs included in Schedule X shall be made in Form 19C accompanied by a 
fee of rupees five hundred, to the licensing authority:] 

Provided  that  in  the  case  of  an  itinerant  vendor  or  an  applicant  who  desires  to 
establish  a  shop  in  a  village  or  town  having  population  of  5,000  or  less,  the 
application in Form 19-A shall be accompanied by a fee of rupees ten . 

(3) 3[A fee of rupees one hundred and fifty] shall be paid for a duplicate copy of 
a licence 2[to sell, stock, exhibit or offer for sale or distribute] drugs, other than those 
included in  Schedule X,  or  for  a  licence  2[to  sell,  stock,  exhibit or  offer  for  sale  or 
distribute] drugs, included in Schedule X, if the original is defaced, damaged or lost: 

Provided  that  in  the  case  of  itinerant  vendor  or  an  applicant  who  desires  to 
establish a shop in a village or town having a population of 5,000 or less, the fee for a 
duplicate copy of a licence if the original is defaced, damaged or lost, shall be rupees 
two. 

(4) Application for renewal of a licence 2[to sell, stock, exhibit or offer for sale or 
distribute]  drugs,  after  its  expiry  but  within  six  months  of  such  expiry  3[shall  be 
accompanied by a fee of rupees one thousand and five hundred plus an additional fee 
at  the rate  of rupees five hundred per month or part  thereof in  Form 19,  rupees five 
hundred plus an additional fee at the rate of rupees two hundred and fifty per month 
or part thereof in Form 19-A and rupees five hundred plus an additional fee at the rate 
of rupees two hundred and fifty per month or part thereof  in Form 19C:] 

Provided that in the case of an itinerant vendor or an applicant desiring to open a 
shop in a village or town having a population of 5,000 or less the application for such 
renewal shall be accompanied by a fee of rupees ten, plus an additional fee at the rate 
of  rupees eight per month or part thereof.] 

1.  Subs. by G.S.R 462 (E), dt. 22-6-1982. 
2.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
3.  Subs. by G.S.R 601 (E), dt. 24-08-2001.

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1[60. A licensing authority may with the approval of the State Government by an 
order in writing delegate the power to sign licences and such other powers as may be 
specified in the order to any other person under his control.] 

2[61. Forms of licences  to sell  drugs. 

(1) a  licence  3[ to sell, stock, exhibit or
offer for sale or distribute] drugs other than those specified in Schedules C, C (1) and 
X  and  by  retail  on  restricted  licence  or  by  wholesale,  shall  be  issued  in  Form  20, 
Form 20A or Form 20B, as the case may be: 

Provided  that  a  licence  in  Form  20A  shall  be  valid  for  only  such  drugs  as  are 

specified in the licence. 

(2) A licence 3[to sell, stock, exhibit or offer for sale or distribute] drugs specified 
in  Schedule  C  and  C  (1)  excluding  those  specified  in  Schedule  X,  by  retail  on 
restricted licence or by wholesale shall be issued in Form 21, Form 21A or Form 21B, 
as the case may be: 

4[Provided that a licence in Form 21A shall not be granted for drugs specified in 
Schedules C and shall be valid for only such Schedule C (1) drugs as are specified in 
the licence.] 

(3 )A licence 3[to sell, stock, exhibit or offer for sale or distribute] drugs specified 
in Schedule X by retail or by wholesale shall be issued in Form 20F or Form 20G as 
the case may be.] 

62. Sale at more than one place. 

If  drugs are sold or stocked for sale at  more
than  one  place,  separate  application  shall  be  made,  and  a  separate  licence  shall  be 
issued, in respect of each such place: 

5[Provided  that  this  shall  not  apply  to  itinerant  vendors  who  have  no  specified 
place  of  business  and  who  will  be  licensed  to  conduct  business  in  a  particular  area 
within the jurisdiction of the licensing authority.] 

1.  Amended by F. 1-16/57-D, dt. 15-6-1957. 
2.  Subs. by G.S.R 462 (E), dt. 22-6-1982. 
3.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
4.  Subs. by  G.S.R 487 (E), dt. 2-7-1984. 
5.  Added by Notfn. No. F. 10-21/49-D, dt. 10-3-1953.

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1[62A. Restricted licences  in  Forms 20A and 21A. 

(a) Restricted licences in
Forms  20A  and  21A  shall  be  issued  subject  to  the  discretion  of  the  Licensing 
Authority, to  dealers or  persons in  respect  of  drugs whose  sale  does  not  require the 
supervision of a qualified person. 

(b) Licences to itinerant vendors shall be issued only in exceptional circumstances 
for  bona  fide  travelling  agents  of  firms  dealing  in  drugs  or  for  a  vendor  who 
purchases  drugs  from  a  licensed  dealer  for  distribution  in  sparsely  populated  rural 
areas where other channels of distribution of drugs are not available. 

(c)  The licensing authority may issue a licence in Form 21A to a travelling agent 
of  a  firm  but  to  no  other  class  of  itinerant  vendors  for  the  specific  purpose  of 
distribution  to  medical  practitioners  or  dealers,  samples  of  biological  and  other 
special products specified in Schedule C: 

Provided  that  travelling  agents  of  licensed  manufacturers,  agents,  of  such 
manufacturers and importers of  drugs shall  be  exempted from taking out  licence  for 
the  free  distribution  of  samples  of  medicines  among  members  of  the  medical 
profession, hospitals, dispensaries and the medical institution or research institutions. 

1[62-B. Conditions to be satisfied before a licence in Form 20A or Form 21A is
(1)  A  licence  in  Form  20A  or  Form  21A  shall  not  be  granted  to  any

granted. 
person,  unless  the  authority  empowered  to  grant  the  licence  is  satisfied  that  the 
premises in  respect of  which the licence is  to  be  granted are  adequate and equipped 
with  proper  storage  accommodation for  preserving  the  properties  of  drugs  to  which 
the licence applies: 

Provided  that  this  condition  shall  not  apply  in  the  case  of  licence  granted  to 

itinerant vendors. 

(2)  In  granting  a  licence  under  Rule  62A  the  authority  empowered to  grant  it 

shall have regard to: 

(i)   the   number   of   licences   granted   in   the   locality   during   one   year 

immediately preceding; and 

(ii) the occupation, trade or business carried on by such applicant : 

1.  Ins. by Notfn. No. F. 1-9/60-D, dt. 3-7-1961.

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Provided that the licensing authority may refuse to grant or renew a licence to any 
applicant or licensee in respect of whom it is satisfied that by reason of his conviction 
of an offence under the Act or these Rules or the previous cancellation or suspension 
of any licence granted thereunder, he is not a fit person to whom a licence should be 
granted under this rule. 

(3) Any person who is aggrieved by the order passed by the licensing authority in 
sub-rule (1) may, within 30 days from the date of the receipt of such order appeal to 
the  State  Government  and  the  State  Government  may,  after  such  enquiry  into  the 
matter  as  it  considers  necessary  and  after  giving  the  appellant  an  opportunity  for 
representing his  views  in  the  matter  make  such  order  in  relation thereto  as  it  thinks 
fit.] 

1[62C. Application for licence to sell drugs by wholesale or to distribute the same
from a motor vehicle.  (1) Application for the grant or renewal of a licence to sell by
wholesale  or  to  distribute  from  a  motor  vehicle  shall  be  made  to  the  Licensing 
Authority  in  Form  19AA  and  shall  be  accompanied  by  2[a  fee  of  rupees  five 
hundred]: 

Provided that if the applicant applies for the renewal of a licence after its expiry 
but  within  six  months  of  such  expiry  ,  the  fee  payable  for  renewal  of  such  licence 
shall be 2[rupees five hundred plus an additional fee at the rate of rupees two hundred 
and fifty per month or part thereof]. 

(2) A fee of 2[rupees one hundred and fifty] shall be paid for a duplicate copy of a 

licence issued under this rule, if the original is defaced, damaged or lost.] 

3[62D.  Form  of  licences  to  sell  drugs  by  wholesale  or  distribute  drugs  from  a
motor  vehicle.  A  licence  shall  be  issued  for  sale  by  wholesale  or  for  distribution
from a  motor vehicle of drugs other than those specified in  Schedule and  Schedule 
C(1) in Form 20BB and of drugs specified in Schedule C and Schedule C(1) in Form 
21BB : 

Provided that such a licence shall not be required in a case where a public carrier 

or a hired vehicle is used for transportation or distribution of drug.] 

3[63. Duration of licence.  An original licence or a renewed licence to sell drugs,
unless sooner suspended or  cancelled, shall  be  2[valid for a  period of  five years on 
and from the date on which] it is granted or renewed: 

1.  Ins. by  Notfn. No. 1-9/60-D dt. 3-7-1961. 
2.  Subs. by Notfn. No. G.S.R 601 (E), dt. 24-8-2001. 
3.  Amended by Notfn. No. F. 1-10/62-D, dt. 10-4-1964.

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1[Provided that if the application for renewal of licence in force is made before its 
expiry or if the application is  made within six months of its expiry, after payment of 
additional fee, the licence shall continue to be in force until orders are passed on the 
application.  The licence shall be deemed to have expired if application for its renewal 
is not made within six months after its expiry].] 

2[63A. Certificate  of renewal of a  sale licence.  The certificate of renewal of  a

sale  licence  in  Forms  20,  20A,  20B,3[20F,  20G],  21,  21A  and  21B  shall  be 
issued in Form 21C.] 

4[63B. Certificate of renewal of licence.  A certificate of renewal of a licence in

Form 20BB or Form 21BB shall be issued in Form 21CC.] 

5[64. Conditions to be satisfied before a licence in Form  8[20, 20B, 20F,20G,
(1)A licence in Form  3[20, 20B, 20F, 20G, 21 or 21B]

21 or 21B] is granted . 
6[to  sell, stock, exhibit or offer for  sale  or distribute] drugs shall not be  granted  7[or 
renewed]  to  any  person  unless  the  authority  empowered  to  grant  the  licence  is 
satisfied  that  the  premises  in  respect  of  which  the  licence  is  to  be  granted  7[or 
renewed] are adequate, equipped with proper storage accommodation for preserving 
the properties of the drugs to which the licence applies and are in charge of a person 
competent in the opinion of the licensing authority to supervise and control the sale, 
distribution and preservation of drugs : 

Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be 
granted 7[or renewed] unless the licensing authority is satisfied that the requirements 
prescribed for a pharmacy in Schedule N have been complied with: 

3[Provided further that licence in Form 20F shall be granted 7[or renewed] only 
to a pharmacy and in areas where a pharmacy is not operating, such licence may be 
7[granted or renewed] to a chemist and druggist.] 

Explanation.  For the purpose of this rule the term ‗Pharmacy‘ shall be held to

mean to  include every  store  or  shop or  other place :  (1)  where drugs are  dispensed, 
that is, measured or weighed or made up and supplied ; or (2) where prescriptions are 
compounded; or (3) where drugs are prepared; or (4) which has upon it or displayed 
within it, or affixed to or used in connection with it, a sign bearing the word or words 
―Pharmacy‖, ―Pharmacist‖,   ―Dispensing Chemist‖  or  ―Pharmaceutical  Chemist‖;  or 
(5)  which, by  sign,  symbol or  indication within or  upon  it  gives the  impression that 
the  operations  mentioned  at  (1),  (2)  and  (3)  are  carried  out  in  the  premises;  or  (6) 
which is advertised in terms referred to in (4) above. 

1.  Amended by S. O. No. 2139, dt. 12-8-1972. 
2.  Ins. by Notfn. No. F. 1-10/62-D, dt. 10-4-1964. 
3.  Ins. by G.S.R 462 (E), dt. 22-6-1982. 
4.  Ins. by Notfn. No. F.1-10/62-D,dt. 10-4-1964. 
5.  Subs. by Notfn. No.F.1-16/57-D,dt. 15-6-1957 and No. F. 1-19/59-D, dt. 13-6-1961. 
6.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
7.  Subs. by  No. G.S.R 681(E), dt. 6-6-1988. 
8. Subs. by G.S.R 462 (E), dt. 22-6-1982.

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 Drugs and Cosmetics Rules 1945 

(2) In granting 1[or renewing] a licence under sub-rule (1) the authority empowered 

to grant it shall have regard 

2[(i)  to the average number of licences granted 1[or renewed] during the 

period of 3 years immediately preceding, and] 

(ii)    to  the  occupation,  trade  or  business  ordinarily  carried  on  by  such 

applicant during the period aforesaid: 

Provided that the licensing authority may refuse to grant or renew a licence to any 
applicant or licensee in respect of whom it is satisfied that by reason of his conviction 
of an offence under the Act or these rules, or the previous cancellation or suspension 
of  any  licence  granted  1[or  renewed]  thereunder,  he  is  not  a  fit  person  to  whom  a 
licence  should  be granted  1[or renewed]  under  this  rule.   Every  such  order  shall  be 
communicated to the licensee as soon as possible: 

3[Provided  further  that  in  respect  of  an  application  for  the  grant  of  a  licence  in 
Form 20B or Form 21B or both, the licensing authority shall satisfy himself that the 
premises in respect of which a wholesale licence is to be granted 1[or renewed] are:- 

(i) of an area of not less than ten square meters; and] 

4[(ii) in the charge of a competent person, who— 

(a) is a Registered Pharmacist, or 

(b)  has  passed  the  matriculation  examination  or  its  equivalent 
examination from a recognised Board with four years‘ experience in dealing 
with sale of drugs, or 

(c)  holds  a  degree  of  a  recognised      University  with  one  year‘s 

experience in dealing with drugs:] 

5[Provided also that,- 

(i) in respect of an application for the grant of a licence in Form 20 or Form 
21 or both, the licensing authority shall satisfy itself that the premises are of an 
area] of not less than 10 square meters, and 

(ii) in respect of an application for the grant of a licence 

(A) In Form 20 or Form 21 or both, and 

(B) In Form 20 B or Form 21B or both, 

the licensing authority shall satisfy itself that the premises are of an area not less  than 
15 square meters: 

1. Ins. by G.S.R 681(E), dt. 6.6.1988. 
2.  Subs. by Notfn. No. F. 1-19/59-D, dt. 13-6-1961. 
3.  Ins. by G.S.R 681(E), dt. 6.6.1980. 
4.  Substituted. G.S.R 351(E), dt. 26-4-2000. 
5.  Ins. by G.S.R 91(E), dt. 25-2-1997. 

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 Drugs and Cosmetics Rules 1945 

Provided also  that  the  provisions of  the  preceding proviso shall  not  apply  to  the 
premises  for  which  licences  have  been  issued  by  the  licensing  authority  before  the 
commencement of the Drugs and Cosmetics (1st Amendment) Rules, 1997.] 

1[(3) Any person who is aggrieved by the order passed by the licensing authority 
in sub-Rule (1) may, within 30 days from the date of receipt of such order, appeal to 
the  State  Government  and  the  State  Government  may,  after  such  enquiry  into  the 
matter  as  it  considers  necessary  and  after  giving  the  appellant  an  opportunity  for 
representing his views in the matter, make such an order in relation thereto as it thinks 
fit.] 

65. Condition of licences.  Licences in  2[Forms 20, 20-A, 20-B, 20-F, 20-G, 21
and 21-B] shall be subject to the conditions stated therein and to the following general 
conditions 

2[(1)  Any  drug  shall,  if  compounded  or  made  on  the  licensee‘s  premises  be 
compounded or made by or under the direct and personal supervision of a 3[registered 
Pharmacist].] 

(2) The supply, otherwise than by way of wholesale dealing, 4[* * *] of any drug 
supplied  on  the  prescription  of  a  Registered  Medical  Practitioner  shall  be  effected 
only by or under the personal supervision of a 3[registered Pharmacist]. 

5[(3) (1) The supply of any drug  6[other than those specified in Schedule X] on a 
prescription  of  a  Registered  Medical  Practitioner  shall  be  recorded  at  the  time  of 
supply  in  a  prescription register  specially  maintained  for  the  purpose  and  the  serial 
number of the entry in the register shall be entered on the prescription.  The following 
particulars shall be entered in the register:_

(a) serial number of the entry, 

(b) the date of supply, 

(c) the name and address of the prescriber, 

7[(d)  the  name  and  address  of  the  patient,  or  the  name  and  address  of  the 

owner of the animal if the drug supplied is for veterinary use, 

(e) the name of the drug or preparation and the quantity or in the case of a 

medicine made up by the licensee, the ingredients and quantities thereof, 

(f)    in  the  case  of  a  drug  specified  in  2[Schedule  C  or  8[Schedule  H  and 
Schedule H1]] the name of the manufacturer of the drug, its batch number and 
the date of expiry of potency, if any, 

(g)  the  signature  of  the  3[registered  Pharmacist]  by  or  under  whose 

supervision the medicine was made up or supplied: 

1.  Amended by F.1-9/60-D dt. 3-7-1961. 
2.  Subs. by G.S.R 462 (E), dt. 22-6-1982. 
3.  Subs. by G.S.R 676 (E), dt.  6-9-1994. 
4.  Omitted by  No. G.S.R 462(E), dt. 22-6-1982. 
5.  Subs. by S. O. 2139, dt. 5-6-1972. 
6.   Ins. by G.S.R. 462(E), dt. 22-6-1982. 
7.  Subs. by G.S.R. 926 dt. 16-7-1977. 
8.  Subs. by G.S.R 588 (E), dt.  30-08-2013.

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 Drugs and Cosmetics Rules 1945 

Provided that in the case of drugs which are not compounded in the premises and 

which  are  supplied  from  or  in  the  original  containers,  the  particulars  specified  in 

items  (a)  to  (g)  above  may  be  entered  in  a  cash  or  credit  memo  book,  serially 

numbered and specially maintained for this purpose: 

Provided  further  that  if  the  medicine is  supplied  on  a  prescription on  which  the 

medicine  has  been  supplied  on  a  previous  occasion  and  entries  made  in  the 

prescription register, it  shall  be  sufficient if  the  new  entry  in  the  register includes a 

serial number, the date of  supply, the quantity supplied and a  sufficient reference to 

an  entry  in  the  register  recording  the  dispensing  of  the  medicine  on  the  previous 

occasion: 

Provided also that it shall not be necessary to record the above details in the 

register or in the cash or credit memo particulars in respect of− 

(i)  any  drugs  supplied  against  prescription  under  the  Employees  State 

Insurance Scheme if all the above particulars are given in that prescription, and 

(ii) any drug other than that specified in  1[Schedule C or  4[Schedule H and Schedule 

H1]] if it is supplied  in  the  original  unopened  container  of  the  manufacturer  and  

if  the prescription is duly stamped at the time of supply with the name of the supplier 

and  the  date  on  which  the  supply  was  made  and  on  condition  that  the  provisions  of 

sub-rule (4)(3) of this rule are complied with. 

5[(h) the supply of a drug specified in Schedule H1 shall be recorded in a separate 

register  at  the  time  of  the  supply  giving  the  name  and  address  of  the  prescriber,  the 

name of the patient, the name of the drug and the quantity supplied and such records 

shall be maintained for three years and be open for inspection.] 

(2) The option to maintain a prescription register or a cash or credit memo book 

in respect of drugs and medicines which are supplied from or in the original container, 

shall be made in writing to  the Licensing Authority at  the time  of application for the 

grant or renewal of the licence to sell by retail: 

Provided that the Licensing Authority may require records to be maintained only 

in prescription register if it is satisfied that the entries in the carbon copy of the cash 

or credit memo book are not legible.] 

2[(4) (1) The supply by retail, otherwise than on a prescription of a drug specified 

in Schedule C  3[* * *] shall be recorded at the time of supply either− 

1.  Subs. by G.S.R 462 (E), dt. 22-6-1982. 
2.  Ins. by Notfn. No. 1-63/61-D, dt. 17-7-1963. 
3.  Omitted by G.S.R 462 (E), dt. 22-6-1982. 
4. Subs. by G.S.R 588 (E), dt.  30-08-2013. 
5. Ins. by G.S.R 588 (E), dt.  30-08-2013.

72 

 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(i)      in  a  register  specially  maintained  for  the  purpose  in  which  the  following 

particulars shall be entered : 

(a)  serial number of the entry, 

(b)  the date of supply, 

(c)  the name and address of the purchaser, 

(d)  the name of the drug and the quantity thereof, 

(e)  in  the  case  of  a  drug  specified  in  Schedule  C,  the  name  of  the 

manufacturer, the batch number and the date of expiry of potency, 

(f)  the  signature  of  the  person  under  whose  supervision  the  sale  was 

effected, or 

(ii)     in  a  cash  or  credit  memo  book,  serially  numbered  containing  all  the 

particulars specified in items (b) to (f) of sub-clause (i) above. 

NOTE:  The entries in the carbon copy of the cash or credit memo which is retained 

by the licensee shall be maintained in a legible manner.

(2) The option to maintain a register or a cash or credit memo book shall be made 
in  writing  to  the  Licensing  Authority  at  the  time  of  application  for  the  grant  or 
renewal of a licence to sell by retail: 

Provided that the Licensing Authority may require records to be  maintained in a 
register if  it  is  satisfied that  the  entries  in  the  carbon  copy  of  the  cash/credit memo 
book are not legible. 

(3)(i)  The supply by retail of any drug shall be made against a cash/credit memo 

which shall contain the following particulars : 

(a)  Name, address and sale licence number of the dealer, 

1[(b) Serial number of the cash/credit memo, 

(c)   the name and quantity of the drug supplied.] 

(ii)  Carbon copies  of  cash/credit memos  shall  be  maintained by  the  licensee  as 

record. 

1.  Ins. by G. S. R. No. 245, dt. 21-2-1976.

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 Drugs and Cosmetics Rules 1945 

1[(4)(i) Records of purchase of a drug intended for sale or sold by retail shall be 
maintained  by  the  licensee  and  such  records  shall  show  the  following  particulars, 
namely: 

(a) the date of purchase, 

(b)  the  name  and  address  of  the  person  from  whom  purchased  and  the 

number of the relevant licence held by him, 

(c) the name of the drug, the quantity and the batch number, and 

(d) the name of the manufacturer of the drug. 

(ii) Purchase bills including cash or credit memo shall be serially numbered by the 

licensee and maintained by him in a chronological order.] 

2[(5)(1)  Subject  to  the  other  provisions  of  these  Rules  the  supply  of  a  drug  by 
wholesale shall be made against a cash or credit memo bearing the name and address 
of the licensee and his licence number under the Drugs and Cosmetics Act in which 
the following particulars shall be entered 

(a) the date of sale, 

(b)  the  name,  address  of  the  licensee  to  whom  sold  and  his  sale  licence 
number.  In case of sale to an authority purchasing on behalf of Government, or 
to  a  hospital,  medical,  educational  or  research  institution  or  to  a  Registered 
Medical  Practitioner  for  the  purpose  of  supply  to  his  patients  the  name  and 
address  of  the  authority,  institution  or  the  Registered  Medical  Practitioner  as 
the case may be, 

(c) the name of the drug, the quantity and the batch number, 

(d) the name of the manufacturer, 

3[(e) the signature of the competent person under whose supervision the sale 

was effected.] 

(2)  Carbon  copies  of  cash  or  credit  memos  specified  in  clause  (1)  shall  be 

preserved as records for a period of three years from the date of the sale of the drug. 

1.  Subs. by G.S.R 1242 (E), dt. 17-9-1979. 
2.  Amended by F. 1-63/62-D, dt. 17-7-1963. 
3.  Ins. by G.S.R 496 (E), dt. 9-6-1995.

74 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(3)  (i)  Records of  purchase of  a  drug intended for resale or  sold by  wholesale 
shall  be  maintained  by  the  licensee  and  such  records  shall  show  the  following 
particulars, namely:- 

(a) the date of purchase, 

(b) the  name, address and the  number of the  relevant licence held by  the 

person from  whom purchased, 

(c) the name of the drug, the quantity and the batch number, and 

(d) the name of the manufacturer of the drug. 

(ii)  Purchase bills including cash  or  credit memos shall  be  serially numbered by 

the licensee and maintained by him in a chronological order.] 

(6) The licensee shall produce for inspection by an Inspector appointed under the 
Act  on  demand  all  registers  and  records  maintained  under  these  Rules,  and  shall 
supply  to  the  Inspector  such  information  as  he  may  require  for  the  purpose  of 
ascertaining  whether  the  provisions  of  the  Act  and  Rules  thereunder  have  been 
observed. 

(7)  Except  where  otherwise  provided  in  these  Rules,  all  registers  and  records 
maintained  under  these  Rules  shall  be  preserved  for  a  period  of  not  less  than  two 
years from the date of the last entry therein. 

(8)  Notwithstanding anything  contained in  this  Rule  it  shall  not  be  necessary  to 
record particulars in a  register specially maintained for the purpose if the particulars 
are  recorded  in  any  other  register  specially  maintained  under  any  other  law  for  the 
time being in force. 

2[(9)  (a)  Substances specified in  3[Schedule H and Schedule H1]  or  Schedule X 
shall  not  be  sold  by  retail  except  on  and  in  accordance  with  the  prescription  of  a 
Registered Medical Practitioner and  in  the  case  of  substances  specified  in  Schedule 
X, the prescriptions shall be in duplicate, one copy of which shall be retained by the 
licensee for a period of two years. 

(b)  The  supply  of  drugs  specified  in  3[Schedule  H  and  Schedule  H1]  or 
Schedule X  to  Registered Medical Practitioners, Hospitals, Dispensaries and Nursing 
Homes  shall  be  made  only  against  the  signed  order  in  writing  which  shall  be 
preserved by the licensee for a period of two years.] 

1.  Subs. by G.S.R 1242(E), dt. 17-9-1979. 
2.  Subs. by G.S.R 462(E), dt. 22-6-1982. 
3. Subs. by G.S.R 588(E), dt. 30-8-2013.

75 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(10)   For the purposes of clause (9) a prescription shall  

(a)  be  in  writing  and  be  signed  by  the  person  giving  it  with  his  usual 

signature and be dated by him; 

1[(b)  specify  the  name  and  address of  the  person for  whose treatment  it  is 
given, or the name and address of the owner of the animal if the drug is meant 
for veterinary use;] 

(c) indicate the total amount of the medicine to be supplied and the dose to 

be taken. 

(11)     The  person  dispensing  a   prescription  containing  a   drug  specified  in 
5[Schedule H and Schedule H1]  2[and  Schedule X]  shall  comply  with  the  following 
requirements in addition to other requirement of these rules. 

(a)   the  prescription  must  not  be  dispensed  more  than  once  unless  the 

prescriber has stated thereon that it may be dispensed more than once; 

(b)   if the prescription contains a direction that it may be dispensed a stated 
number of times or at  stated intervals it  must not be dispensed otherwise than 
in accordance with the directions; 

(c)    at the time of dispensing there must be noted on the prescription above 
the signature of the prescriber the name and address of the seller and the date 
on which the prescription is dispensed. 

4[(11-A)   No person dispensing a prescription containing substances specified in 
3[5[Schedule H and Schedule H1] or X], may supply any other preparation, whether 
containing the same substance or not, in lieu thereof. 

3[(12) Substances specified in Schedule X kept in retail shop or premises used in 

connection therewith shall be stored— 

(a) under lock and key in cupboard or drawer reserved solely for the storage 

of these substances; or 

(b)  in  a  part  of the premises separated from the  remainder of  the  premises 

and to which only responsible persons have access;] 

1.  Subs.  by G. S. R. No. 926, dt. 24-6-1977. 
2.  Ins. by  G.S.R 462 (E), dt. 22-6-1982. 
3.  Subs., by  G.S.R 462 (E), dt. 22-6-1982. 
4.  Ins. by SO 2139, dt. 5-6-1972. 
5. Subs. by G.S.R 588(E), dt. 30-8-2013.

76 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1 [*   *     *   *    *] 

2[(15)(a) The description ―Drugstore‖ shall be displayed by such licensees who do 

not require the services of a 3[Registered Pharmacist]. 

(b)  The  description  ―Chemists  and  Druggists‖  shall  be  displayed  by   such 
licensees  who  employ  the  services  of  a  3[Registered  Pharmacist]  but  who  do  not 

maintain a ―Pharmacy‖ for compounding against prescriptions. 

(c)  The  description  ―Pharmacy‖,  ―Pharmacist‖,  ―Dispensing  Chemist‖  or 

―Pharmaceutical  Chemist‖  shall  be  displayed  by  such  licensees  who  employ  the 

services of  a  3[Registered Pharmacist] and  maintain a  ―Pharmacy‖ for  compounding 

against prescriptions: 

3[Explanation:- For the purpose of this rule,- 

(i)  ―Registered  Pharmacist‖    means  a  person  who  is  a  registered 

Pharmacist  as  defined  in  clause  (i)  of  section  (2)  of  the  Pharmacy  Act,  1948 

(Act No. 8 of 1948): 

Provided  that  the  provisions  of  sub-clause  (i)  shall  not  apply  to  those 

persons  who  are  already  approved  as  ―qualified  person‖  by  the  licensing 

authority on or before 31st December, 1969: 

(ii)  ―Date  of  Expiry  of  potency‖  means  the  date  that  is  recorded  on  the 

container,  label  or  wrapper  as  the  date  up  to  which  the  substance  may  be 

expected to  retain  a  potency  not  less  than  or  not  to  acquire  a  toxicity  greater 

than that required or permitted by the prescribed test].] 

4[(16)  The  licensee  shall  maintain  an  Inspection  Book  in  Form  35  to  enable  an 

Inspector to record his impressions and the defects noticed.] 

1.  Sub-Rules (13) and (14) omitted by G.S.R 462 (E), dt. 22-6-1982. 
2.  Subs. by Notfn. No. F. 1-16/57-D, dt. 15-6-1957. 
3.  Subs. by G.S.R 676 (E), dt. 6-9-1994. 
4.  Subs. by Notfn. No. F. 1-14/68-D dt. 26-10-1968.

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 Drugs and Cosmetics Rules 1945 

1[(17) No drug shall be sold or stocked by the licensee after the date of expiration 

of potency recorded on its container, label or wrapper, or in violation of any statement 

or direction recorded on such container, label or wrapper: 

Provided that any such drugs in respect of which the licensee has taken steps with 

the manufacturer or his representative for the withdrawal, reimbursement or disposal 

of  the  same,  may  be  stocked  after  the  date  of  expiration  of  potency  pending  such 

withdrawal, reimbursement or  disposal, as  the  case  may  be,  subject to  the  condition 

that  the  same  shall  be  stored  separately  from  the  trade  stocks  2[and  all  such  drugs 

shall be kept in  packages or cartons, the top of which shall display prominently, the 

words ―Not for sale‖].] 

3[(18) No drug intended for distribution to the medical profession as free sample 
which bears a label on the container as specified in clause 4[(ix)] of sub-rule (1) of rule 

96,  and  no  drug  meant  for  consumption  by  the  Employees‘  State  Insurance 

Corporation,  the  Central  Government  Health  Scheme,  the  Government  Medical 

Stores  Depots,  the  Armed  Forces  Medical  Stores  or  other  Government  institutions, 

which  bears  a  distinguishing  mark  or  any  inscription  on  the  drug  or  on  the  label 

affixed to the container thereof indicating this purpose shall be sold or stocked by the 

licensee on his premises:] 

5[Provided  that  this  sub-rule  shall  not  be  applicable  to  licensees  who  have  been 

appointed  as  approved  chemists,  by  the  State  Government  in  writing,  under  the 

employees‘  State  Insurance  Scheme,  or  have  been  appointed  as  authorised  agent  or 

distributor,  by  the  manufacturer  in  writing,  for  drugs  meant  for  consumption  under 

the Central Government Health Scheme, the Government Medical Stores Depots, the 

Armed  Forces  Medical  Stores  or  other  Government Institutions for  drugs  meant  for 

consumption under those schemes  6[or  have  been appointed as  authorised Depots or 

Carrying  and  Forwarding  agent  by  the  manufacturer  in  writing,  for  storing  free 

samples  meant  for  distribution  to  medical  profession]  subject  to  the  conditions  that 

the stock shall be stored separately from the trade stocks and shall maintain separate 

records of the stocks received and distributed by them.] 

1.  Ins. by Notfn. No. F. 1-55/61-D, dt. 22-8-1964. 
2.  Ins. by S. O. No. 903, dt. 28-2-1976. 
3.  Ins.  by Notfn. No. 1-113/69-D, dt. 23-12-1969. 
4. Subs. by G.S.R. 676(E) dt. 6-9-1994. 
5.  Subs. by G.S.R. 496(E) dt. 9-6-1995. 
6.  Ins. by G.S.R 352(E), dt. 26-4-2000. 

78 

 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(19) The supply by retail of any drug in a container other than the one in which 
the manufacturer has marketed the drug, shall be made only by  dealers who employ 
the  services  of  a  2[Registered  Pharmacist]  and  such  supply  shall  be  made  under  the 
direct  supervision  of  the  2[Registered  Pharmacist]  in  an  envelope  or  other  suitable 
wrapper or container showing the following particulars on the label: 

(a) name of the drug, 

(b) the quantity supplied, 

(c) the name and address of the dealer.] 

3[(20) The  medicines for  treatment of  animals kept  in  a  retail  shop  or  premises
for treatment of animals only‘

shall be labelled with the words ‗Not for human use 
and shall be stored 

(a)  in  a  cupboard  or  drawer  reserved  solely  for  the  storage  of  veterinary 

drugs, or 

(b)   in a part of the premises separated from the remainder of the premises 

to which customers are not permitted to have access.] 

4[(21)  (a)  The  supply  of  drugs  specified  in  Schedule  X  shall  be  recorded  at  the 
time of supply in a register (bound and serially page numbered) specially maintained 
for the purpose and separate pages shall be allotted for each drug. 

(b) The following particulars shall be entered in the said register, namely:-- 

(i) Date of transaction; 

(ii) Quantity received, if any, the name and address of the supplier   and the 

number of the relevant licence held by the supplier; 

(iii) Name of the drug; 

(iv) Quantity supplied; 

(v) Manufacturer‘s name; 

(vi) Batch No. or Lot No; 

(vii) Name and address of the patient/purchaser; 

(viii)  Reference  Number  of  the  prescription  against  which  supplies  were 

made; 

(ix) Bill No and date in respect of purchases and supplies made by him; 

(x)  Signature  of  the  person  under  whose  supervision  the  drugs  have  been 

supplied.] 

1.  Ins. by G. S. R. 444 dt. 28-4-1973. 
2.  Subs. by G.S.R 676 (E), dt. 6-9-1994. 
3.  Added by G. S. R. No. 926 dt. 16-7-1977. 
4.  Ins. by G.S.R 462 (E), dt. 22-6-1982.

79 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[65A.  Additional information to be furnished by an applicant for liscence or a
licensee to the Licensing Authority.  The applicant for the grant of a licence or any
person  granted  a  licence  under  this  Part  shall,  on  demand,  furnish  to  the  licensing 
authority, before the grant of the licence or during the period   the licence is in force, 
as the case may be, documentary evidence in respect of the ownership of occupation 
or rental or other basis of the premises, specified in the application for licence or in 
the licence granted, constitution of the firm, or any other relevant matter which may 
be required for the purpose of verifying the correctness of the statements made by the 
applicant or the licensee, while applying for or after obtaining the licence, as the case 
may be.] 

66. Cancellation and suspension of licences. 

(1) The Licensing Authority may,

after giving the licensee an opportunity to show cause why such an order should not 
be passed by an order in writing stating the reasons therefor, cancel a  licence issued 
under  this  Part  or  suspend  it  for  such  period  as  he  thinks  fit,  either  wholly  or  in 
respect of some of the substances to which it relates, if in his opinion, the licensee has 
failed to  comply with any of  the  conditions of the licence or  with any  provisions of 
the Act or Rules thereunder: 

1[Provided that, where such failure or contravention is the consequence of an act 
or omission on the part of an agent or employee, the licence shall not be cancelled or 
suspended if the licensee proves to the satisfaction of the licensing authority−  

(a) that the act or omission was not instigated or connived at by him or, if the 
licensee  is  a  firm  or  company,  by  a  partner  of  the  firm  or  a  director  of  the 
company, or 

(b)  that  he  or  his  agent  or  employee  had  not  been  guilty  of  any  similar  act  or 
omission  within  twelve  months  before  the  date  on  which  the  act  or  omission  in 
question took place, or where his agent or employee had been guilty of any such act 
or omission the licensee had not or could not reasonably have had, knowledge of that 
previous act or omission, or 

(c)  if  the  act  or  omission was  a  continuing act  or  omission, he  had  not  or could 

not reasonably have had knowledge of that previous act or omission, or 

(d) that he had used due diligence to ensure that the conditions of the licence or 

the provisions of the Act or the Rules thereunder were observed.] 

2[(2) A licensee whose licence has been suspended or cancelled may, within three 
months of the date of order under sub-rule (1), prefer an appeal against that order to 
the State Government, which shall decide the same.] 

3[66A. Procedure for disposal of  drugs in the event  of  cancellation of licence.— 
(1)  In  case  a  licensee,  whose  licence  has  been  cancelled,  desires  to  dispose  of  the 
drugs he has in his possession in the premises in respect of which the licence has been 
cancelled, he shall apply in writing to the licensing authority for this purpose, giving 
the following particulars, namely:— 

1.  Ins. by S. O. 2139, dt. 12-8-1972. 
2.  Subs. by G. S. R. 926 dt. 16-7-1977. 
3.  Ins. by G.S.R 1242 (E), dt. 17-9-1979.

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 Drugs and Cosmetics Rules 1945 

(a)  the name and address of the person to whom the drugs are proposed to 
be  sold  or  supplied  together  with  the  number  of  the  licence  for  sale  or 
manufacture, as the case may be, held by him, 

(b)   the  names of  drugs together with their quantities, batch numbers, the 
names and addresses of their manufacturers and the dates of their expiry, if any, 
proposed to be sold to the person mentioned in clause (a). 

(2) The licensing authority may, after examination of the particulars referred to in 
sub-rule (1) and, if necessary, after inspection by an Inspector of the premises where 
the drugs are stocked, grant the necessary permission for their disposal.] 

       6

[****] 

1[PART VIA 

SALE OF HOMOEOPATHIC MEDICINES 

67A.      (1)  The  State  Government  shall  appoint  Licensing  Authorities  for  the 

purpose of this Part for such areas as may be specified. 

(2) Application for the grant or renewal of a licence  2[to sell, stock or exhibit or 
offer for sale or distribute] Homoeopathic medicines shall be  made in Form 19-B to 
the Licensing Authority and shall be  accompanied by  a  3[fee  of  rupees two hundred 
and fifty]: 

4[Provided that if the applicant applies for renewal of licence after its  expiry but 
within six months of such expiry the fee payable for renewal of such licence shall be 
3[rupees two hundred and fifty plus an additional fee at the rate of rupees fifty or part 
thereof]. 

5[(3)  If  the  original  licence  is  either  defaced,  damaged  or  lost,  a  duplicate  copy 

thereof may be issued on payment of a 3[fee of rupees fifty].] 

67B. A Licensing Authority may, with the approval of the State Government, by 
an order in writing, delegate the power to sign licences and such other powers, as may 
be specified, to any other person under his control. 

67C. Forms of licences to sell drugs.  (1)   A licence 2[to sell, stock or exhibit or
offer for sale or distribute] Homoeopathic medicines by retail or by wholesale shall 
be issued in Form 20C or 20D as the case may be. 

1.  Added by Notfn. No. F. 1-35/64-D, dt. 18-8-1964. 
2.  Subs. by G.S.R 788(E) dt. 10-10-1985. 
3.  Subs. by G.S.R 601 (E), dt. 24-8-2001. 
4.  Amended by S. O. 2139 dt. 12-8-1972. 
5.  Added by G. S. R. 665, dt. 28-5-77. 
6. Rule 67 omitted by SO 289 (E), dt. 20-12-1972.

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 Drugs and Cosmetics Rules 1945 

67D. Sale at more than one place. 

If drugs are sold or stocked for sale at more
than one place, a  separate application shall be made and a  separate licence shall be 
obtained in respect of each place. 

67E. Duration of licences.  An original licence or a renewed licence unless it is
sooner suspended or cancelled shall be 1[valid for a period of five years on and from 
the date on which]  it is granted or renewed : 

2[Provided that if the application for renewal of a licence in force is made before 
its expiry or if the application is made within six month of its expiry, after payment of 
additional fee, the licence shall continue to be in force until orders are passed on the 
application  and  the  licence  shall  be  deemed  to  have  expired  if  application  for  its 
renewal is not made within six months after its expiry.] 

3[67EE. Certificate  of renewal.  The certificate  of renewal of a  sale licence in

Forms 20C and 20D shall be issued in Form 20E.] 

67F.  Condition  to  be  satisfied  before  a  licence  in  Form  20C  or  Form  20D  is 
granted.-(1)  A  licence  in  Form  20C  or  Form  20D  to  4[to  sell,  stock  or  exhibit  or 
offer  for  sale  or  distribute]  Homoeopathic  medicines  shall  not  be  granted  to  any 
person  unless  the  authority  empowered  to  grant  the  licence  is  satisfied  that  the 
premises in respect of which the licence is to be granted are clean and in the case of a 
licence  in  Form  20C  the  sale  premises  is  in  charge  of  a  person  who  is  or  has  been 
dealing  in  Homoeopathic  medicines  and  who  is  in  the  opinion  of  the  Licensing 
Authority competent to deal in Homoeopathic medicines: 

5[Provided   that   no   registered   Homoeopathic   medical   practitioner   who   is 
practising  Homoeopathy  in  the  premises  where  Homoeopathic  medicines  are  sold 
shall deal in Homoeopathic medicines.] 

(2) Any person who is aggrieved by the order passed by the Licensing Authority 
under  sub-rule  (1)  may  within  30  days  from  the  date  of  the  receipt  of  such  order 
appeal  to  the  State  Government  and  the  State  Government  may,  after  such  enquiry 
into the matter as it considers necessary and after giving the appellant an opportunity 
for representing his case, make such order in relation thereto as it thinks fit. 

1.  Subs. by G.S.R 601 (E), dt. 24-8-2001. 
2.  Subs. by S. O. 2139 dt. 5-6-1972. 
3.  Added by Notfn. No. F. 1-14/67-D, dt. the 3-2-1969. 
4.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
5.  Ins. by Notfn. No. G.S.R 680 (E), dt. 5-12-1980.

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67G. Conditions of licence.  Licence in Form 20C or 20D shall be subject to

the conditions stated therein and to the following further conditions, namely: 

(1) The premises where the Homoeopathic medicines are stocked for sale or 

sold are maintained in a clean condition. 

(2)  The  sale  of  Homoeopathic  medicines  shall  be  conducted  under  the 

supervision of a person, competent to deal in Homoeopathic medicines. 

(3)  The  licensee  shall  permit  an  Inspector  to  inspect  the  premises  and 
furnish  such  information  as  he  may  require  for  ascertaining  whether  the 
provisions of the Act and the Rules made thereunder have been observed. 

(4)  The  licensee  in  Form  20D  shall  maintain records  of  purchase and  sale 
of  Homoeopathic  medicines  containing  alcohol  together  with  names  and 
addresses of parties to whom sold. 

1[(5) The licensee in Form 20C shall maintain records of purchase and sale 
of Homoeopathic medicines containing alcohol.   No records of sale in respect 
of  Homoeopathic  potentised  preparation  in  containers  of  30  ml.  or  lower 
capacity and in respect of mother tinctures made up in quantities up to 60 ml. 
need be maintained.] 

2[(6) The licensee shall maintain an  Inspection Book in  Form 35  to enable 

an Inspector to record his impressions and the defects noticed.] 

3[67GG. Additional information to be furnished by an applicant for licence or a
licensee to the Licensing Authority.  The applicant for the grant of a licence or any
person  granted  a  licence  under  this  Part  shall,  on  demand  furnish  to  the  Licensing 
Authority, before the grant of the licence or during the period the licence is in force 
as the case may be, documentary evidence in respect of the ownership or occupation 
or rental or other basis of the premises, specified in the application for licence or in 
the  licence  granted,  constitution  of  the  firm,  or  any  other  relevant  matter,  which 
may be required for the purpose of verifying the correctness of the statements made 
by the applicant or the licensee, while applying for or after obtaining the licence, as 
the case may be.] 

1. Ins. by Notfn. No. F. 1-59/68-D, dt. the 19-11-1969. 
2.  Ins. by G.S.R 331 (E), dt. 8-5-1984. 
3.  Ins. by S. O. 2139 dt. 5-6-1972.

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67-H.  Cancellation  and  suspension  of  licences.  (1)  The  Licensing  Authority

may, after giving the licensee an opportunity to show cause why such an order should 

not  be  passed  by  an  order  in  writing  stating  the  reasons  therefor,  cancel  a  licence 

issued under this Part or suspend it for such period as he thinks fit, if in his opinion, 

the licensee has failed to comply with any of the conditions of the licence or with any 

provisions of the Act or Rules made thereunder: 

1[Provided that, where such failure or contravention is the consequence of an act 

or omission on the part of an agent or employee, the licence shall not be cancelled or 

suspended if the licensee proves to the satisfaction of the Licensing Authority−

(a)  that the act or omission was not instigated or connived at by him or, if 

the licensee is a firm or company, by a partner of the firm or a director of the 

company, or 

(b)   that he or his agent or employee had not been guilty of any similar act 

or omission within twelve months before the date on which the act or omission 

in question took place, or where his agent or employee had been guilty of any 

such  act  or  omission,  the  licensee  had  not  or  could  not  reasonably  have  had, 

knowledge of that previous act or omission, or 

(c)   if the act or omission was a continuing act or omission that he had not 

or could not reasonably have had knowledge of that previous act  or omission, 

or 

(d)  that  he  had  used  due  diligence  to  ensure  that  the  conditions  of  the 

licence or the provisions of the Act or the Rules thereunder were observed.] 

2[(2) A licensee whose licence has been suspended or cancelled may, within three 

months of the date of the order under sub-rule (1), prefer an appeal against that order 

to the State Government, which shall decide the same.] 

1.  Ins. by S. O. 2139 dt. 5-6-1972. 
2.  Amended by G.S.R. 926 dt. 16-7-1977.

84 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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PART   VII 

1[MANUFACTURE   FOR    SALE  OR  FOR  DISTRIBUTION] OF   DRUGS  

OTHER THAN HOMOEOPATHIC MEDICINES 

68. Manufacture on more than one set of premises. 

If drugs are manufactured
on more than one set of premises a separate application shall be made and a separate 
licence shall be issued in respect of each such set of premises. 

2[68-A.  Grant  or  Renewal  of  Licences  by  the  Central  Licence  Approving 
Authority.—  (1)  Notwithstanding  anything  contained  in  this  Part,  on  and  from  the 
commencement of  the  Drugs and  Cosmetics (Amendment) Rules,1992, a  licence for 
the manufacture for sale or  distribution of drugs as specified from time to time by the 
Central  Government  by  notification  in  the  Official  Gazette,  for  the  purpose  of  this 
rule,  shall  be  granted  or  renewed,  as  the  case  may  be,      by  the  Central  Licence 
Approving Authority (appointed by the Central Government):] 

                        Provided that the application for the grant or renewal of such licence 
shall be made to the Licensing Authority. 

(2)  On  receipt of  the  application for  grant  or  renewal of  a  licence, the  licensing 

authority shall,- 

(i)  verify the statement made in the application form; 

(ii)  cause  the  manufacturing  and  testing  establishment  to  be  inspected  in 

accordance with the provisions of rule 79; and 

(iii)  in  case  the  application  is  for  the  renewal  of  licence,  call  for  the 

information(s) of the past performance of the licensee. 

(3) If the licensing authority is satisfied that the applicant is in a position to fulfil 
the requirements laid down as in these Rules, he shall prepare a  report to that effect 
and forward it along with the application  3[and   the   licence   (in   triplicate)  to   be 
granted and renewed, duly completed] to the Central Licence Approving Authority: 

Provided that if the licensing authority is of the opinion that the applicant is not in 
a  position to fulfil the requirements laid  down in  these Rules, he  may, by  order, for 
reasons to be recorded in writing, refuse to grant or renew the licence, as the case may 
be. 

(4)  If on  receipt  of the  application  and  the  report  of the  licensing  authority 
referred to in sub-rule (3) and after taking such measures including inspection of the 
premises by the Inspector, appointed by the Central Government under section 
21   of   the   Act,   with  or  without  an  expert  in  the  concerned  field  if  deemed 
necessary,  the Central Licence Approving Authority, is satisfied that the applicant 

1.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
2.  Ins. by G.S.R 923 (E), dt. 14-12-1992. 
3.  Subs. by G.S.R 89 (E), dt. 14-2-1996.

85 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

is  in  a  position  to  fulfil the requirements laid down in these Rules, he may grant or 
renew the licence, as the case may be: 

Provided  that  if  the  Central  Licence  Approving  Authority  is  of  the  opinion  that 
the applicant is not in a position to fulfil the requirements laid down in these rules, he 
may, notwithstanding the report of the licensing authority, by order, for reasons to be 
recorded in writing, reject the application for grant or renewal of licence, as the case 
may be.] 

1[68B.  Delegation of  Powers  by  the  Central  Licence Approving Authority.—The 
Central  Licence  Approving  Authority  may  with  the  approval  of  the  Central 
Government,  by  notification  delegate  his  powers  of  signing  licences  and  any  other 
powers under the rules to any person under his control having same qualifications as 
prescribed  for  controlling  authority  under  Rule  50A  for  such  areas  and  for  such 
periods as may be specified.] 

2[69.  Application for  licence  to  manufacture drugs  other  than  those  specified in 
Schedules C and C(I) to the Drugs and Cosmetics Rules.      3[(1) Application for grant 
or renewal of 4[licence to manufacture for sale or for distribution] of drugs, other than 
those  specified  in  Schedules  C  and  C(I)  shall  be  made  to  the  licensing  authority 
appointed  by  the  State  Government  for  the  purpose  of  this  Part  (hereinafter  in  this 
Part referred to as the licensing authority) and shall be made 

(a) in the case of repacking of drugs excluding those specified in Schedule 

X for sale or distribution in, Form 24B; 

(b)  in  the  case  of  manufacture of  drugs  included in  Schedule X,  in  Form 

24F; 

(c) in any other case, in Form 24.] 

5[(2)(a)  Every  application  in  Form  24B  shall  be  made  up  to  ten  items  for  each 
category of drugs categorised in Schedule M and shall be accompanied by a  licence 
fee of rupees five hundred plus and an inspection fee of rupees two hundred for every 
inspection or for the purpose of renewal of the licence. 

1.  Ins. by G.S.R 89 (E), dt. 14-02-1996. 
2.  Amended by Notfn. F. 1-22/59-D, dt. 9-4-1960. 
3.  Subs. by G.S.R 462 (E), dt. 22-06-1982. 
4  Subs. by G.S.R.788 (E), dt. 10-10-1985. 
5.  Subs. by G.S.R 601(E), dt. 21-8-2001.

86 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(b)  Every  application  in  Form  24F  shall  be  made  up  to  ten  items  for  each 
category of drugs categorised in Schedule M and shall be accompanied by a  licence 
fee  of  rupees  six  thousand  and  an  inspection  fee  of  rupees  one  thousand  and  five 
hundred for every subsequent inspection or for the purpose of renewal of licence. 

(c) Every application in Form 24 shall be made up to ten items for each category 
of  drugs  3[referred  to  in  Schedule  M  relating  to  pharmaceuticals  products  and 
Schedule  MIII  relating  to  medical  devices  and  in-vitro  diagnostics]  and  shall  be 
accompanied  by  a  licence  fee  of  rupees  six  thousand  and  an  inspection  fee  of  one 
thousand  and  five  hundred for every inspection or for the purpose of renewal of the 
licence.] 

1[(3)  If  a  person applies for  the renewal of  a  licence after the  expiry  thereof but 
within six months of such expiry the fee payable for the renewal of such licence shall 
be−]

2[(i)  in  the  case  of  Form 24B  a  licence fee  of  rupees five  hundred plus  an 
additional  fee  at  the  rate  of  rupees  two  hundred  and  fifty  per  month  or  part 
thereof in addition to an inspection fee of rupees two hundred; 

(ii)  in  the  case  of  Form  24F  a  licence  fee  of  rupees  six  thousand  plus  an 
additional fee  at  the  rate  of  rupees one  thousand per  month or  part  thereof in 
addition to an inspection fee of rupees one thousand; 

(iii)  in  the  case  of  Form  24  a  licence  fee  of  rupees  six  thousand  plus  an 
additional fee  at  the  rate  of  rupees one  thousand per  month or  part  thereof in 
addition to an inspection fee of rupees one thousand and five hundred.] 

1[(4)  A  fee  2[rupees  one  thousand  shall  be  paid]    for  a  duplicate  copy  of  the 
licence issued under clause (a), clause (b) or clause (c) of sub-Rule (1) if the original 
is defaced, damaged or lost.] 

2[(5)  Applications  for  manufacture  of  more  than  ten  items  of  each  category  of 
drugs  as  categorized  under  Schedule  M  and  M-III  or  for  manufacture  of  additional 
items  of  drugs  by  licensees  in  Form  24  or  Form  24F  shall  be  accompanied  by  an 
additional  fee  at  the  rate  of  rupees  three  hundred  for  each  additional  item  of  drug. 
Applications  in  Form  24B  for  licence  to  manufacture  for  sale  and  distribution  for 
repacking  for  more  than  10  items  of  each  category  or  for  manufacture  of  additional 
item of drug shall be accompanied by additional fee of rupees one hundred for each 
additional item of drugs as cetegorized in Schedule M and M-III]. 

1.  Subs. by G.S.R 462 (E), dt. 22-6-1982. 

2.  Subs. by G.S.R 26 (E), dt. 19-1-2006. 

3.  Subs. by G.S.R 640 (E), dt. 29-6-2016.

87 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(6)  Where  an  application  under  this  Rule  is  for  the  manufacture  of  drug 
formulations  falling  under  the  purview  of  new  drug  as  defined  in  rule  122E,  such 
application  shall  also  be  accompanied  with  approval,  in  writing  in  favour  of  the 
applicant, from the licensing authority as defined in clause (b) of rule 21.] 

2[69A.  Loan  Licences.⎯3[(1)  Application  for  the  grant  or  renewal  of  loan 
licences to manufacture for sale or for distribution of drugs other than those specified 
in Schedule C, Schedule C (1) and Schedule X shall be made up to ten items for each 
category of drugs 5[referred to in Schedule M relating to pharmaceuticals products and 
Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be made 
in Form 24A accompanied by a licence fee of rupees six thousand and an inspection 
fee of rupees one thousand and five hundred to the licensing authority: 

Provided that if the applicant applies for the renewal of a licence after its expiry 
but within six months of such expiry, the fee payable for renewal of such licence shall 
be  accompanied  by  a  licence  fee  of  rupees  six  thousand  and  an  inspection  fee  of 
rupees one thousand and five hundred plus an additional fee at the rate of rupees one 
thousand per month or part thereof.] 

4[Explanation.- For the purpose of this rule a loan licence means a licence which 
the    Licensing  Authority  may    issue  to    an    applicant  who    does  not    have  his  own 
arrangements for manufacture but who intends to avail himself of the manufacturing 
facilities owned by a licensee in Form 25.] 

(2)  The  Licensing  Authority  shall,  before  the  grant  of  a  loan  licence,  satisfy 
himself  that  the  manufacturing  unit  has  adequate  equipment,  staff,  capacity  for 
manufacture, and facilities for testing, to undertake the manufacture on behalf of the 
applicant for a loan licence. 

3[(3)  Subject  to  the  provisions  of  sub-rule  (2),  application  for  manufacture  of 
more than ten items for each category of drug on a loan licence shall be accompanied 
by an additional fee of rupees three hundred per additional item specified 5[referred to  
in  Schedule  M  relating  to  pharmaceuticals  products  and  Schedule  MIII  relating  to 
medical devices and in-vitro diagnostics]. 

1.  Ins. by G.S.R 311 (E), dt. 1-5-2002. 
2.  Amended by Notfn. No. F. 1-16/57-D, dt. 15-6- 1957. 
3.  Subs. by G.S.R 601(E) dt. 24-8-2001. 
4.  Subs. by G.S.R 724(E) dt. 07-11-2013. 
5.  Subs. by G.S.R 640 (E), dt. 29-6-2016.

88 

 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(4)    If  the  Licensing  Authority  is  satisfied  that  a  loan  licence  is  defaced, 
damaged  or  lost  or  otherwise  rendered  useless,  he  may,  on  payment  of  a  2[fee  of 
rupees one thousand] issue a duplicate licence.] 

3[*   *   *   *  *] 

4[70. Form of licence to repack or manufacture drugs other than those specified 

in  Schedules C  and  C(1).- 
  Licences  for repacking of drugs against application in Form 24-B shall be granted in 
Form  25-B,  licences  for  manufacture  of  drugs  included  in  Schedule  X  and  against 
application in  Form 24-F shall be  granted in  Form 25-F and licences for manufacture 
of drugs against application in Form 24 shall be granted in Form 25.] 

5[70A. Form of loan 6[licence to manufacture for sale or for distribution] of drugs 

other  than  those  7[specified  in  Schedules  C,  C(1)  and  X].⎯ 
A  loan  6
7[specified in Schedules C, C(1) and X] shall be issued in Form 25A.] 

[licence  to manufacture for sale or for distribution] or drugs other than those 

8[71.   Conditions  for  the  grant  or  renewal  of  a  licence  in  Form  25  9[or  Form 

25F].⎯ 

Before a licence in Form 25 9[or Form 25F] is granted or renewed, the  
following conditions shall be complied with by the applicant.- 

(1)    The  manufacture  shall  be  conducted  under  the  active  direction  and 
personal supervision of competent technical staff consisting at least of one person 
who is a whole-time employee and who is 

(a)  a  graduate  in  Pharmacy  or  Pharmaceutical  Chemistry  of  10[a 
University  established  in  India  by  law  or  has  an  equivalent  qualification 
recognised  and  notified  by  the  Central  Government  for  such  purpose]   and 
has had at least eighteen months practical experience after the graduation in 
the  manufacture  of  drugs.      This  period  of  experience  may,  however,  be 
reduced by six months if the person has undergone training in manufacture of 
drugs for a period of six months during his University  course; or 

(b)    a    graduate    in    Science    of     10[a    University    established 
in   India   by   law   or   has   an   equivalent   qualification   recognized   and 
notified by the Central Government for   such   purpose] who for the purpose 
of   his degree   has   studied   Chemistry   as  a   principal   subject   and  has 

1.  Ins. by  Notfn. No. F.1-20/64-D, dt. 26.10.1968. 
2.  Subs. by Notfn. No. G.S.R. 601 (E), dt. 24.8.2001. 
3.  Rule 69 omitted by G.S.R. 944 (E), dt. 21-9-1988. 
4.  Subs. by Notfn. No. G.S.R. 462 (E), dt. 22.6.1982. 
5.  Ins. by Notfn. No. F.1-16/57 D,  15-6-1957 & No. F.1/22/59-D, dt. 9.4.1960. 
6.  Subs. by Notfn. No. G.S.R. 788 (E), dt. 10-10-1985. 
7.  Subs. by Notfn. No. G.S.R. 462 (E), dt. 22-6-1982. 
8.  Subs. by Notfn. No. F.1-16/57-D, dt. 15-6-1957. 
9. Ins. by G.S.R. 462(E), dt. 22-6-1982. 
10.  Subs. by Notfn. No. G.S.R. 71 (E), dt. 30-1-1987.

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had at least three years practical experience in the manufacture of drugs after 
his graduation; or 

(c) a graduate in Chemical Engineering or Chemical Technology or Medicine 
of  1[a University established in India by law or has an equivalent qualification 
recognised  and  notified  by  the  Central  Government  for  such  purpose]  with 
general  training  and  practical  experience,  extending  over  a  period  of  not  less 
than three years in the manufacture of drugs, after his graduation; or 

2[(d) holding any foreign qualification the quality and content of training of 
which are comparable with those prescribed in clause (a), clause (b) or clause 
(c) and is permitted to work as competent technical staff under this Rule by the 
Central Government:] 

Provided  that  any  person  who  was  immediately  before  the  29th  June,  1957, 
actively  directing  and  personally  supervising  the  manufacture  of  drugs  and  whose 
name was accordingly entered in any licence granted in Form 25 3[or Form 25F] as it 
existed before the date shall be deemed to be qualified for the purposes of this rule: 

4[Provided further that  for drugs other than  those specified in  Schedules C,  C(1) 
and  X  and  meant  for  veterinary  use,  the  whole-time  employee  under  whose 
supervision the manufacture is conducted shall be a graduate in Veterinary Science or 
Pharmacy or  General Science or Medicine of a University recognized by the Central 
Government  and  who  has  had  at  least  three  years  practical  experience  in  the 
manufacture  of  drugs  excluding  graduate  in  Pharmacy  who  shall  have  at  least 
eighteen months practical experience in the manufacture of drugs:] 

5[Provided 6[also] that the Licensing Authority may, in the matter of manufacture 
of  disinfectant  fluids,  insecticides,  liquid  paraffin,  medicinal  gases,  non-chemical 
contraceptives, plaster of  Paris  and  surgical  dressings, for  the  manufacture of  which 
the knowledge of Pharmaceutical Chemistry or Pharmacy is not essential, permit the 
manufacture of  the  substance under  the  active  direction  and  personal  supervision of 
the  competent  technical  staff,  who,  although  not  having  any  of  the  qualifications 
included  in  clause  (a),  (b)  or  (c)  of  this  rule,  has,  in  the  opinion  of  the  Licensing 
Authority, adequate experience in the manufacture of such substance.] 

1.  Subs. by  G.S.R. 71(E), dt. 30-1-1987. 
2. Added by Notfn. NO. F. 1-19/59-D, dt. 13-6-1961. 
3.  Ins. by. G.S.R. 462 (E), dt. 22-6-1982. 
4.  Ins. by. G.S.R. 93 (E), dt. 24-2-1999. 
5.  Added Notfn. No. F. 1-14/68-D, dt. the 26-10-1968. 
6. Sub. by. G.S.R. 93 (E), dt. 24-2-1999.

90 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(2)   The   factory   premises   shall   comply   with   the   conditions   prescribed  in 

Schedule M. 

(3)  The  applicant  shall  provide  adequate  space,  plant  and  equipment  for  the 
manufacturing operations; the  space,  plant  and  equipment recommended for  various 
operations are given in Schedule M. 

1[(4)  The  applicant  shall  provide  and  maintain  adequate  staff,  premises  and 
laboratory equipment for  carrying out  tests  of  the  strength, quality  and  purity  of  the 
substances at a testing unit, which shall be separate from the manufacturing unit and 
the  head  of  the  testing  unit  shall  be  independent  of  the  head  of  the  manufacturing 
unit : 

Provided  that  the  manufacturing  units,  which,  before  the  commencement of  the 
Drugs  and  Cosmetics  (Amendment)  Rules,  1977,  were  making  arrangements  with 
institutions  approved  by  the  Licensing  Authority  for  such  tests  to  be  carried  out  on 
their behalf may continue such arrangements up to the 30th June, 1977 : 

Provided further  that  for  tests  requiring sophisticated instrumentation techniques 
or  biological or  microbiological methods other than sterility the  Licensing Authority 
may  permit  such  tests  to  be  conducted  by  institutions  approved  by  it  4 [ under 
Part XV(A) of these rules] for this purpose.] 

2[(4A)  The  head  of  the  testing  unit  referred  to  in  condition  (4)  shall  possess  a 
degree  in  Medicine  or  Science  or  Pharmacy  or  Pharmaceutical  Chemistry  of  a 
University  recognized  for  this  purpose  and  shall  have  experience  in  the  testing  of 
drugs, which in the opinion of the licensing authority is considered adequate.] 

(5)  The  applicant  shall  make  adequate  arrangements  for  the  storage  of  drugs 

manufactured by him. 

3[(6)  The  applicant  shall,  while  applying  for  a  licence  to  manufacture  patent  or 
proprietary medicines, furnish to the Licensing Authority evidence and data justifying 
that the patent or proprietary medicines 

(i)  contain the constituent ingredients in therapeutic/prophylactic quantities 
as  determined in  relation to  the  claims  or  conditions for  which  the  medicines 
are recommended for use or claimed to be useful; 

1.  Subs. by G.S.R. 926 dt. 16-7-1977. 
2.  Ins. by  G.S.R. 681(E), dt. 5-12-1980. 
3.  Ins. by G.S.R. 515 dt. 10-4-1976. 
4. Ins. by G.S.R. 1172 dt. 23-8-1977.

91 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(ii) are safe for use in the context of the vehicles, excipients, additives and 
pharmaceutical aids used in the formulation and under the conditions in which 
the formulation for administration and use are recommended; 

(iii) are stable under the conditions of storage recommended; 

(iv)  contain  such  ingredients  and  in  such  quantities  for  which  there  is 

therapeutic justification; and] 

1[(v) have the approval, in writing, in favour of the applicant to manufacture 
drugs formulations falling under the purview of new drug as defined in Rule 
122-E, from the Licensing Authority as defined in clause (b) of rule 21.] 

2[(7)  The  licensee  shall  comply  with  the  requirements  of  Good  Manufacturing 

Practices as laid  down in Schedule M.] 

6[(8) The applicant shall make application for grant of licence for a drug formulation 
containing single active ingredient only in proper name.] 

3[71A. Conditions for the grant or renewal of a licence in Form 25B. Before a licence  in  
Form  25B  is  granted  or  renewed  the  following  conditions shall be complied with by the 
applicant :- 

(1)  the  repacking  operation  shall  be  carried  out  under  hygienic  conditions  and 

under the supervision of a competent person; 

4[(2)   the   factory   premises  shall   comply   with   the   conditions  prescribed  in 

Schedule M; and] 

5[(3)   the  applicant  shall  have  adequate  arrangements  in  his  own  premises  for 
carrying  out  tests  for  the  strength,  quality  and  purity  of  the  drugs  at  a  testing  unit 
which shall be separate from the repacking unit:] 

6[(4) The application for grant of licence for a drug formulation containing single 

active ingredient shall be made only in proper name:] 

Provided that the repacking units, which before the commencement of the Drugs 
and  Cosmetics  (Second  Amendment)  Rules,  1977,  were  making  arrangements  with 
institutions approved by the licensing authority for such tests to be carried out on their 
behalf, may continue such arrangements up to the 31st July, 1977: 

1.  Ins. by G.S.R. 311 (E), dt. 1-5-2002. 
2.  Ins. by G.S.R. 735 (E), dt. 24-6-1988. 
3.  Ins. by  No. F.1-22/59-D, dt.  9-4-1960. 
4.  Amended by  S.O. 2139 dt. 12-8-1972. 
5.  Amended by G.S.R. 926  dt. 16-7-1977. 
6. Ins. by G.S.R. 570 (E), dt. 7-8-2014.

92 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

Provided  further  that  for  tests  requiring  sophisticated instrumentation techniques 
or biological or microbiological methods the licensing authority may permit such test 
to  be  conducted by  institutions approved by  it  under Part XV(A)  of  these  Rules  for 
this purpose.] 

Explanation.−A person who satisfies the following minimum qualifications shall 

be deemed to be a ―competent person‖ for the purposes of rule 71A or 74A of these 
rules, namely: − 

(a) a person who holds the Diploma in Pharmacy approved by the Pharmacy 
Council of India under the Pharmacy Act, 1948 (VIII of 1948) or a person who is 

registered under the said Act, or 

(b)  a  person who  has  passed  the  Intermediate examination with  Chemistry 
as  one  of  the  principal  subjects  or  an  examination  equivalent  to  it  or  an 
examination recognized by the Licensing Authority as equivalent to it; or 

(c)    a    person    who    has    passed    the    Matriculation    examination    or    an 
examination recognized by the Licensing Authority as equivalent to it and has 
had   not  less   than   four  years‘  practical  experience  in   the   manufacture, 
dispensing or repacking of drugs.] 

1[71B.  Conditions  for  the  grant  of  renewal  of  a  licence  in  Form  25A.−  Before  a 

licence in Form 25A is granted or renewed, the applicant shall, while applying for a 
licence  to    manufacture  patent  or    proprietary  medicines,  furnish  to    the  Licensing 
Authority evidence and data justifying that the patent or proprietary medicines:- 

(i) contain the constituent ingredients in therapeutic/prophylactic quantities as 
determined  in  relation  to  the  claims  or  conditions  for  which  the  medicines are 
recommended for use or claimed to be useful; 

(ii)  are  safe  for  use  in  the  context  of  the  vehicles,  recipients,  additives  and 
pharmaceutical aids  used  in  the  formulations and  under  conditions in  which  the 
formulations for administration and use are recommended; 

(iii) are stable under the conditions of storage recommended; and 

(iv)  contain  such  ingredients  and  in  such  quantities  for  which  there  is 

therapeutic justification. 

2[Provided  that  the  application  for  grant  of  a  licence  for  a  drug  formulation 

containing single active ingredient shall be made only in proper name.] 

1.  Ins. by G.S.R. 515 (E), dt. 24-3-1976. 
2. Ins. by G.S.R. 570 (E), dt. 7-8-2014.

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1[72.   Duration   of   licence.–An   original   licence   or   a   renewed   licence   in 

Form 25,  2[Form 25B or Form 25F] unless sooner suspended or cancelled shall be 
3[valid  for  a  period  of  five  years  on  and  from  the  date  on  which]  it  is  granted  or 
renewed: 

4[Provided that  if  the  application for  the  renewal of  a  licence is  made  before  its 
expiry, or if the application is made within six months of its expiry, after payment of 
additional fee, the licence shall continue to be in force until orders are passed on the 
application and the licence shall be deemed to have expired if the application for its 
renewal is not made within six months of its expiry.] 

2[73. Certificate of renewal.– The certificate of renewal of a licence in Form 25 or 

Form 25F shall be issued in Form 26 or Form 26E respectively]. 

5[73A.   A  certificate  of  renewal  of  loan  licence.-  The  certificate  of  renewal  of  a 

loan licence in Form 25A shall be issued in Form 26A.] 

5[73AA.  Duration  of  loan  licence.–  An  original  loan  licence  in  Form  25A  or  a 

renewed loan licence in Form 26A, unless sooner suspended or cancelled, shall be 
3[valid  for  a  period  of  five  years  on  and  from  the  date  on  which]  it  is  granted  or 
renewed:] 

6[Provided that  if  the  application for  the  renewal of  a  licence  is  made  before its 
expiry, or if the application is made within six months of its expiry, after payment of 
additional fee, the licence shall continue to be in force until orders are passed on the 
application and the licence shall be deemed to have expired if the application for its 
renewal is not made within six months of its expiry.] 

7[73B.   Certificate of renewal of licence in Form 25B.–The certificate of renewal 

of a licence in Form 25B shall be issued in Form 26B.] 

1.  Subs. by Notfn. No. F.1-10/62-D, dt. 10-4-1964. 
2.  Subs. by G.S.R. 462 (E), dt. 22-6-1982. 
3.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
4.  Amended by  S.O. 2139 dt. 12-8-1972. 
5.  Amended by Notfn. No. F.1-10/62-D, dt. 10-4-1964. 
6.  Amended by S.O. 2139 dt. 12-8-1972.  
7.  Ins. by  S.O. 1196, dt. 6-5-1960.

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1[74. Conditions of licence in Form 25.−A licence in 2[Form 25 and Form  
25F] shall  be  subject  to  the  conditions  stated  therein  and  to  the  following  
further conditions, namely : 

(a)  the  licensee  shall  provide  and  maintain  staff,  premises  and  the 

equipment as specified in rule 71; 

(b)  the  licensee  shall  comply  with  the  provisions  of  the  Act  and  of  these 
rules  and  with  such  further  requirements,  if  any,  as  may  be  specified  in  any 
rules  subsequently  made  under  Chapter  IV  of  the  Act;  provided  that  where 
such  further  requirements  are  specified  in  the  Rules,  these  would  come  into 
force, four months after publication in the Official Gazette; 

(c) the licensee shall either in his own laboratory or in any other laboratory 
approved  by  the  Licensing  Authority  4 [ under  Part  XV  (A)  of  these  rules] 
test each  batch or  lot  of  the  raw  material  used  by  him  for  the  manufacture of 
his products and also each batch of the final product and shall maintain records 
or registers  showing  the  particulars  in  respect  of  such  tests  as  specified  
in  Schedule  U.    The  records  or  registers  shall  be  retained  for  a  period  of  5 
years from the date of manufacture; 

(d)  the  licensee  shall  keep  records  of  the  details  of  manufacture  as  per 
particulars  given  in  Schedule  U  of  each  batch  of  the  drugs  manufactured  by 
him and such records shall be retained for a period of five years; 

(e)  the  licensee  shall  allow  an  3[ Inspector  appointed  under  the  Act],  to 
enter, with  or  without  prior  notice,  any  premises and  to  inspect the  plant  and 
the  process  of  manufacture  and  the  means  employed  in  standardizing  and 
testing the drugs; 

(f)  the  licensee  shall  allow  an  3[ Inspector  appointed  under  the  Act]  to 
inspect  all  registers  and  records  maintained  under  these  rules  and  to  take 
samples  of  the  manufactured  drugs  and  shall  supply  to  such  Inspector  such 
information  as  he  may  require  for  the  purpose  of  ascertaining  whether  the 
provisions of  the Act and the rules thereunder have been observed; 

(g) the licensee shall, from time to time, report to  the Licensing Authority 
any changes in the expert staff responsible for the manufacture or testing of the 
drugs and any material alterations in the premises or plant used for the purpose 
which have been   made   since   the   date of the last inspection made on behalf 
of the licensing authority; 

1.  Subs. by  Notfn. No. F. 1-20/64-D (S.O. 3868), dt. 26-10-1968. 
2.  Subs. by G.S.R. 462 (E), dt. 22-6-1982. 
3.  Amended by G.S.R. 444 dt. 28-4-1973. 
4. Ins. by G.S.R. 1172 (E), dt. 23-8-1977.

95 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[ (h)  the  licensee  shall,  on  request, furnish to  the  Licensing Authority, the 
Controlling Authority or to such authorities as the   Licensing Authority or the 
Controlling Authority may direct from every batch, or batches of drugs as the 
Licensing  Authority  or  the  Controlling  Authority  may  from  time  to  time 
specify,  a  sample  of  such  quantity  as  may  be  considered  adequate  by  such 
authority for any examination and, if so required, also furnish full protocols of 
tests which have been applied;] 

(i) if the Licensing Authority  2[or the Controlling Authority] so directs and 
if  requested  by  the  licensee  who  had  also  furnished  prima  facie  reasons  for 
such directions, the licensee shall not sell or offer for sale any batch in respect 
of  which  a  sample  is  or  protocols  are  furnished  under  clause  (h)  until  a 
certificate  authorizing  the  sale  of  the  batch  has  been  issued  to  him  by  or  on 
behalf of the Licensing Authority 2[or the Controlling Authority; 

(j) the licensee shall on being informed by the Licensing Authority 2[or the 
Controlling Authority] that any part of any batch of the drug has been found by 
the Licensing Authority 2[or the Controlling Authority]not to conform with the 
standards  of  strength,  quality  or  purity  specified  in  these  rules  and  on  being 
directed so to do, withdraw the remainder of the batch from sale, and, so far as 
may in the particular circumstances of the case be practicable, recall all issues 
already made from that batch; 

(k) the licensee shall maintain an Inspection Book in Form 35 to enable an 

Inspector to record his impressions and the defects noticed; 

1[(l)  the  licensee  shall  maintain  reference  samples  from  each  batch  of  the 
drugs manufactured by him in a quantity which is at least twice the quantity of 
the  drug  required to  conduct all  the  tests  performed on  the  batch.   In  case  of 
drugs  bearing  an  expiry  date  on  the  label,  the  reference  samples  shall  be 
maintained for a period of three months beyond the date of expiry or potency. 
In  case of  drugs where no  date of expiry of  potency is  specified on the label, 
the reference samples shall be maintained for a period of three years from the 
date of manufacture;] 

2[(m)   the licensee, who has been granted a licence in Form 25F, shall- 

(i)     forward  to the licensing authority of the concerned States  of 
manufacture and  supply of  the  drug  a  statement of  the  sales  effected to 
manufacturers, wholesalers, retailers, hospitals, dispensaries and  nursing 
homes and Registered Medical Practitioners every three months; 

(ii)     maintain   accounts    of    all   transactions  giving    details    as 
indicated below in a register bound and serially page numbered and such 
records shall be retained for a period of five years or one year after the 
expiry of potency, whichever is later:- 

1.  Subs. by G.S.R. No. 444  dt. 31-3-1973. 
2. Ins. by G.S.R. No. 444  dt. 31-3-1973. 
3.  Ins. by G.S.R. 462 (E), dt. 22-6-1982.

96 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

A.   Accounts of   the drugs   specified   in   Schedule   X   used   for   the 
manufacture: 

1.    Date of issue. 

2.    Name of the drug. 

3.    Opening balance of stock on the production day. 

4.    Quantity received, if any, and source from where received. 

5.    Quantity used in manufacture. 

6.    Balance quantity on hand at the end of the production day. 

7.    Signature of the person in charge. 

B.  Accounts of production: 

1.    Date of manufacture. 

2.    Name of the drug. 

3.    Batch Number. 

4.    Quantity of raw material used in manufacture. 

5.    Anticipated yield. 

6.    Actual yield, 

7     Wastage, 

8.    Quantity of the manufactured goods transferred. 

C.  Accounts of the manufactured drugs: 

1.    Date of manufacture. 

2.    Name of the drug. 

3.    Batch Number. 

4.    Opening Balance. 

5.    Quantity manufactured. 

6.    Quantity sold. 

7.    Name of the purchaser and his address. 

8.    Balance quantity at the end of the day. 

9.    Signature of the person in charge. 

(n)  the  licensee shall  store  drugs specified in  Schedule X  in  bulk form 
and when any of such drug is required for manufacture in a place other than 
its  place  of  storage  it  shall  be  kept  in  a  separate  place  under  the  direct 
custody of a responsible person;] 

1[(o)   the  licensee  shall  comply  with  the  requirements  of   2[Good 
in  Schedule  L-I  and]  ‗Good 

Laboratory  Practices  as 
Manufacturing Practices‘ as laid down in Schedule M.] 

laid  down 

3[(p)  No  advertisement  of the  drugs  specified in  Schedule  H,  Schedule 
H1 and Schedule X shall be made except with the previous sanction of the 
Central Government.] 

1.  Ins. by G.S.R. 735 (E), dt. 24-6-1988. 
2.  Ins by G.S.R. 780 (E), dt. 10-11-2008. 
3. Ins by G.S.R. 289 (E), dt. 15-04-2015. 

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 Drugs and Cosmetics Rules 1945 

74A. Conditions  for  licence  in  Form  25B._  A  licence  in  Form  25B  shall  be 

subject to the conditions stated therein and to the following conditions:_

(a)  the repacking of drugs shall at all times be conducted under the personal 
supervision of  at  least  one  person who  is  approved as  a  competent person by 
the Licensing Authority; 

(b)  the licensee shall either provide and maintain adequate arrangements in 
his own premises for carrying out tests of the strength, quality and purity of the 
drugs  repacked  or  make  arrangements  with  some  institution  approved  by  the 
Licensing  Authority  3[under  Part  XV  (A)  of  these  rules]  for  such  tests  to  be 
regularly carried out on his behalf by the institution; 

(c)  the licensee shall make adequate arrangements for the storage of drugs; 

2[(d)  the licensee shall comply with the provisions of the Act and of these 
rules  and  with  such  further  requirements,  if  any,  as  may  be  specified  in  any 
rules subsequently made under Chapter IV of the Act: 

Provided  that  where  such  further  requirements  are  specified  in  the  Rules, 
these  would  come  into  force  four  months  after  publication  in  the  Official 
Gazette.] 

(e)    the  licensee  shall  allow  any  4[Inspector  appointed  under  the  Act]  to 
enter  with  or  without  notice,  any  premises  where  the  packing  of  drugs  in 
respect of which the licence is issued is carried on, to inspect the premises and 
to take samples of repacked drugs; 

2[(f)  the licensee shall, either in his own laboratory or, in any other laboratory 
approved  by  the  Licensing  Authority,  test  each  batch  or  lot  of  raw  material 
used by     him for repacking and also each batch of the product thus repacked 
and  shall    maintain  records  or  registers  showing  the  particulars  in  respect  of 
such tests as  specified  in  Schedule  U.  The    records  or  registers  shall  be 
retained  for  a    period of five years from the date of repacking.  The licensee 
shall  allow  the  Inspector to  inspect all  registers and  records maintained under 
these rules and shall supply to the Inspector such information as he may require 
for  the  purpose  of  ascertaining  whether  the  provisions  of  the  Act  and  these 
rules have been observed;] 

1.  Ins. by G.S.R. 735 (E), dt. 24-6-1988. 
2.   Subs. by Notfn. No. F.1-20/64-D, dt. 26-10-1968. 
3. Ins. by G.S.R. 1172 (E), dt. 23-8-1977. 
4. Subs. by G.S.R. 444 (E), dt. 31-3-1973.

98 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(g)   the licensee shall maintain an Inspection Book, in Form 35, to enable 

an Inspector  to record his impressions and the defects noticed;] 

2[(h)   the licensee shall maintain reference samples from each batch of the 

drugs manufactured by him in a quantity which is at least twice the quantity of 

the  drug  required to  conduct all  the  tests  performed on  the  batch.   In  case  of 

drugs  bearing  an  expiry  date  on  the  label,  the  reference  sample  shall  be 

maintained for a period of three months beyond the date of expiry of potency. 

In  case of  drugs where no  date of expiry of  potency is  specified on the label, 

the reference samples shall be maintained for a period of three years from the 

date of manufacture. 

4[(i) No advertisement of the drugs specified in Schedule H, Schedule H1 or 

Schedule  X  shall  be  made  except  with  the  previous  sanction  of  the  Central 

Government.] 

3[74B.Conditions of licence in Form 25A. 

(1) The licence in Form 25A

shall  be  deemed  to  be  cancelled  or  suspended,  if  the  licence  owned  by  the 

licensee  in  Form  25,  whose  manufacturing facilities  have  been  availed  of  by 

the licensee, is cancelled or suspended, as the case may be, under these rules. 

(2)  The  licensee shall  comply  with  the  provisions of  the  Act  and  of  these  rules 

and  with  such  further  requirements  if  any,  as  may  be  specified  in  any  rules 

subsequently  made  under  Chapter  IV  of  the  Act;  provided  that  where  such  further 

requirements are specified in the rules, these would come into force four months after 

publication in the Official Gazette. 

(3) The licensee shall test each batch or lot of the raw material used by him for 

the  manufacture  of  his  products  and  also  each  batch  of  the  final  product  and  shall 

maintain  records  or  registers  showing  the  particulars  in  respect  of  such  tests  as 

specified in Schedule U.  The records or registers shall be retained for a period of five 

years from the date of manufacture.  The licensee shall allow an Inspector to inspect 

all registers and records maintained under these rules and shall supply to the Inspector 

such  information  as  he  may  require  for  the  purpose  of  ascertaining  whether  the 

provisions of the Act and these rules have been observed. 

1.  Ins. by Notfn. No. 1-14/68-D, dt. 26-10-1968. 
2.  Ins. by G.S.R. 444 (E) dt. 31-3-1973 . 
3.  Subs. by Notfn. No. F. 1-14/68-D, dt. the 26-10-1968. 
4.  Ins. by G.S.R. 289 (E) dt. 15-4-2015.

99 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(4) The licensee shall either- 

(i)  provide  and  maintain  to  the  satisfaction  of  the  Licensing  Authority 
adequate  staff  and  adequate  laboratory  facilities  for  carrying  out  test  of  the 
strength, quality and purity of the substances manufactured by him, or 

(ii)  make  arrangements  with  some  institution  approved  by  the  Licensing 
Authority  7[under Part XV (A)  of  these  rules]  for  such  tests  to  be  regularly 
carried out on his behalf by the institution. 

1[(5)   The licensee shall maintain reference samples from each batch of the drugs 
manufactured  by  him  in  a  quantity  which  is  at  least  twice  the  quantity  of  the  drug 
required to conduct all the tests performed on the batch.   In case of drugs bearing an 
expiry  date  on  the  label  the  reference  samples  shall  be  maintained  for  a  period  of 
three months beyond the date of expiry of potency.  In case of drugs where no date of 
expiry of potency is specified on the label, the reference samples shall be maintained 
for a period of three years from the date of manufacture.] 

2[(6)   The licensee shall  maintain an  Inspection Book in  Form 35  to  enable an 

Inspector to record his impressions and the defects noticed.] 

8[(7)  No  advertisement  of  the  drugs  specified  in  Schedule  H,  Schedule  H1  or 
Schedule  X  shall  be  made  except  with  the  previous  sanction  of  the  Central 
Government.] 

3[75.   Form of  application for licence to  manufacture for sale or distribution of 
drugs specified in Schedules C and C(1) and X 4[excluding those specified in Part XB 
and Schedule X]._(1) Applications for the grant or renewal of licence to manufacture 
for sale or distribution of drugs specified in Schedules C and C(1)  4[excluding  those 
specified in  Part X-B  and  Schedule X],  shall  be  made to  the  Licensing Authority in 
Form 27 and 5[shall be made up to ten items for each category of drugs 6[referred to in 
Schedule  M  relating  to  pharmaceuticals  products  and  Schedule  M-III  relating  to 
medical devices and in-vitro diagnostics] and  shall  be  accompanied by  a  licence fee 
of rupees six thousand and an inspection fee of rupees one thousand and five hundred 
for every inspection or for the purpose of renewal of licences:] 

Provided that  if  the  applicant applies  for  renewal  of  licence  after  its  expiry  but 
within six months of such expiry, the fee payable for renewal of the licence shall be 
5[a  licence fee  of  rupees six  thousand plus an  additional fee  of  rupees one  thousand 
per  month  or  a  part  thereof  in  addition to  an  inspection fee  of  rupees  one  thousand 
and five hundred.] 

(2)  Application  for  grant  or  renewal  of  licence  to  manufacture  for  sale  or 
distribution  of  drugs  specified  in  Schedules  C,  C(1)  and  X  shall  be  made  to  the 
licensing  authority  in  Form  27-B,  and  5[shall  be  made  up  to  ten  items  for  each 
category  of  drugs   6[referred to in Schedule M relating to pharmaceuticals products 
and  Schedule M-III  relating  to  medical  devices  and  in-vitro  diagnostics]    and    shall  
be  accompanied  by  a  licence  fee  of  rupees  six  thousand  and  an  inspection  fee  of 
rupees one thousand five hundred for every inspection or for the purpose of renewal 
of licences]: 

1.  Ins. by G.S.R.. No. 444, dt. 28-4-1973.           7. Subs. by G.S.R. 1172(E), dt.  23-8-1977. 
2.  Ins. by G.S.R. 331 (E), dt. 8-5-1984.               8. Ins. by G.S.R. 289(E), dt.  15-4-2015. 
3.  Subs. by G.S.R. 462 (E), dt. 22-6-1982. 
4.  Subs. by G.S.R. 28(E), dt.  22-1-1993. 
5.  Subs. by G.S.R. 601(E), dt. 24-8-2001. 
6.  Subs. by G.S.R. 640(E), dt. 29-6-2016.

100 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

Provided  that  the  applicant  shall  possess  a  licence  in  Form  28  to  manufacture 

such drugs: 

Provided further that  if  the  application for  renewal of  a  licence is  made after its 
expiry but within six months of such expiry, the fee payable for renewal of the licence 
shall  be  1[rupees  six  thousand  plus  an  additional  fee  of  rupees  one  thousand  per 
month  or  part  thereof  in  addition  to  an  inspection fee  of  rupees  one  thousand five 
hundred.] 

2[(3) The application for grant or renewal of licence to manufacture for sale or for 
distribution  of  drugs  in  4[Large  Volume  Parenterals,  Sera  and  Vaccine  and 
Recombinant DNA (r-DNA) derived drugs]  shall  be made  to  the licensing authority 
appointed under this Part in Form 27D and  1[shall be made up  to  ten  items for each 
category of drugs categorized in Schedule M and shall be  accompanied  by  a  licence 
fee  of  rupees  six  thousand  and  an  inspection  fee  of  rupees  one  thousand  five 
hundred for every inspection or for the purposes of renewal of licences:] 

Provided that  if  the  application for  renewal  of  a  licence is  made  after  its  expiry 
but within six months of such expiry, the fee payable for renewal of the licence 1[shall 
be rupees six thousand plus an additional fee of rupees one thousand per month or a 
part  thereof  in  addition  to  the  inspection  fee  of  rupees  one  thousand  and  five 
hundred.] 

1[(4) A fee of rupees one thousand shall be paid for duplicate copy of the licence 
issued  under  sub-rule  (1),  sub-rule  (2)  or  sub-rule  (3),  as  the  case  may  be,  if  the 
original licence is defaced, damaged or lost. 

(5) If the licensee applies for manufacture of more than ten items of each category 
of  drugs,  the  application  shall  be  accompanied  by  an  additional  fee  at  the  rate  of 
rupees  three  hundred  for  each  additional  item  of  drugs  5[referred to in Schedule M 
relating to pharmaceuticals products and Schedule M-III relating to medical devices 
and in-vitro diagnostics].] 

3[(6)  Where  an  application  under  this  Rule  is  for  the  manufacture  of  drug 
formulations falling under the purview of new drugs as defined in Rule 122-E, such 
application  shall  also  be  accompanied  with  approval,  in  writing,  in  favour  of  the 
applicant, from the licensing authority as defined in clause (b) of Rule 21.]] 

1.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
2.  Ins. by G.S.R. 119 (E), dt. 11-3-1996. 
3.  Ins. by G.S.R. 311 (E), dt. 1-5-2002. 
4. Subs. by G.S.R. 26 (E), dt. 19-1-2006. 
5. Subs. by G.S.R. 640 (E), dt. 29-6-2016.

101 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 
1[75A.    Loan    licences.−(1)  Applications    for    the    grant    or    renewal    of    loan 
2[licences for  the  manufacture for  sale or  for  distribution] of  drugs specified in 
Schedules C and C(1) 3[excluding those specified in Part X-B and Schedule X] shall 
be made in Form 27-A to the licensing authority and  4[shall be   made upto ten items 
for  each  category  of  drugs  14[referred to in  Schedule  M relating  to  pharmaceuticals 
products and Schedule M-III relating to medical devices and in-vitro diagnostics] and 
shall be accompanied by a fee of rupees  six thousand and an inspection fee of rupees 
one thousand  and  five  hundred  for  every  inspection  or  for  the  purpose  of  renewal 
of licences:] 

5[Provided that if the applicant applies for the renewal of a licence after its expiry 
but within six months of such expiry the fee payable for renewal of the licence shall 
be 4[rupees six thousand and an inspection of fee of rupees one thousand five hundred 
plus an additional fee at the rate of rupees one thousand] per month or a part thereof.] 

11[Explanation. − For the purpose of this rule a loan licence means a licence which 
a licensing authority may issue to an applicant who intends to avail the manufacturing 
facilities owned by a licensee in Form 28.] 

12[(1A)   The application  for grant or renewal of loan license to manufacture for 
sale or  distribution of  drugs  in ‗Large Volume  Parenterals‘,  ‗Sera  and Vaccine‘ and 
‗Recombinant DNA (r-DNA) derived drugs‘ shall be made to the licensing authority 
appointed  under  this  Part,  in  Form  27DA  and  be  made  upto  ten  items  for  each 
category of drugs categorized in Schedule M and accompanied by a license fee of six 
thousand rupees and an inspection fee of one thousand five hundred rupees for every 
inspection or for the purpose of renewal of licenses: 

Provided that if the application for renewal of a license is made after its expiry but 
within six months of such expiry, the fee payable for renewal of the license shall be 
six thousand rupees plus an additional fee of one thousand rupees per month or a part 
thereof in addition to the inspection fee of one thousand and five hundred rupees;] 

(2)        The  licensing  authority,  shall,  before  the  grant  of  a  loan  licence,  satisfy 
himself  that  the  manufacturing  unit  has  adequate  equipment,  staff,  capacity  for 
manufacture and  facilities  for  testing  to  undertake the  manufacture on  behalf  of  the 
applicant for a loan licence. 

13[***] 
4[(3) Subject to the provisions of sub-rule (2), the application for manufacture of 
more than ten items of each category of drugs on a loan license, shall be accompanied 
by  an  additional  fee  at  the  rate  of  rupees  three  hundred  for  each  additional  item  of 
drugs. 

(4)    If the licensing authority is satisfied that a loan licence is defaced, damaged 
or lost, he may, on payment of a fee of rupees one thousand, issue a duplicate copy of 
loan licence.] 

6[*  *   *  *   *] 
7[76. 8[Forms of licence to manufacture drugs specified in Schedules C and C(1), 
9[excluding  those  specified  in  Part  XB  and  Schedule  X],  or  drugs  specified  in 
Schedules  C,  C(1)  and  X  and  the  conditions  for  the  grant  or  renewal  of  such 
licences.- 10[A licence to manufacture for sale or for distribution of drugs specified in 

1.  Ins. by F.1-16/57-D, dt. 15-6-1957. 
2.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
3.  Subs. by G.S.R 28 (E), dt. 22-1-1993. 
4.  Subs. by G.S.R 601 (E), dt. 24-8-2001. 
5.  Amended by S.O.2139 dt. 13-8-1972. 
6.  Rule 75B omitted by G.S.R. 944 (E), dt. 21-9-1988. 
7.  Amended by F- 1- /57-D, dt. 15-6-1969. 
8.  Subs. by G.S.R. 462 (E), dt. 22-6-1982. 
9.  Subs. by G.S.R. 28 (E) , dt. 22.1.1993. 
10.  Subs. by G.S.R. 119 (E), dt. 11-3-1996. 
11. Subs. by G.S.R. 724 (E), dt. 7-11-2013. 
12. Ins. by G.S.R. 574 (E) , dt. 17.7.2012.  
13. Proviso omitted by G.S.R. 574 (E) , dt. 17.7.2012. 
14. Subs. by G.S.R. 640 (E), dt. 29-06-2016.

102 

 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

Schedules  C  and  C(1)  other  than  4[Large Volume  Parenterals, Sera and Vaccine 
and Recombinant DNA (r-DNA) derived drugs] specified in Part X B and Schedule 
X shall be issued in Form 28 and a licence to manufacture for sale or distribution of 
drugs specified under Schedules C and C(1) (other than 4[Large Volume  Parenterals, 
Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs]  specified in  Part 
X-B)  and  Schedule  X  shall  be  issued  in  Form  28B.  A  licence  to  manufacture  for 
sale  or  for  distribution  of  4[Large  Volume    Parenterals,  Sera  and  Vaccine  and 
Recombinant DNA (r-DNA) derived drugs] shall be issued in Form 28-D. Before a 
licence in Form 28 or Form 28B or Form 28D is granted or renewed, the following 
conditions shall be complied with by the applicant:- 

(1)     The manufacture will be conducted under the active direction and personal 
supervision of  competent  technical  staff  consisting  at  least  of  one  person  who  is  a 
whole time employee and who is 

(a)  a  graduate in  Pharmacy or  Pharmaceutical  Chemistry of  1[a  University 
established  in  India  by  law  or  has  an  equivalent  qualification  recognized  and 
notified  by  the  Central  Government  for  such  purpose]  and  has  had  at  least 
eighteen  months‘  practical experience after  the  graduation in  the  manufacture 
of drugs to  which this licence applies; this period of experience may however 
be reduced by six months if the person has undergone training in manufacture 
of  drugs  to  which  the  licence  applies  for  a  period  of  six  months  during  his 
University course; or 

(b)  a  graduate  in  Science  of  1[a  University  established in  India  by  law  or 
has  an  equivalent  qualification  recognized  and  notified  by  the  Central 
Government for  such  purpose] who  for  the  purpose of  his  degree  has  studied 
Chemistry  3[or Microbiology] as a  principal subject and has had at  least  three 
years‘  practical  experience  in  the  manufacture  of  drugs  to  which  this  licence 
applies after his graduation; or 

(c) a  graduate in Medicine of  1[a  University established in  India by  law or 
has  an  equivalent  qualification  recognized  and  notified  by  the  Central 
Government  for  such  purpose]  with  at  least  three  years‘  experience  in  the 
manufacture  and  pharmacological  testing  of  biological  products  after  his 
graduation; or 

2[(d) a graduate in Chemical Engineering of a University recognised by the 
Central  Government  with  at  least  three  years‘  practical  experience  in  the 
manufacture of drugs to which this licence applies after his graduation; or 

(e)  holding  any  foreign  qualification the  quality  and  content  of  training  of 
which are comparable with those prescribed in clause (a), clause (b), clause (c) 
or  clause (d)  and  is  permitted to  work  as  competent technical staff under this 
Rule by the Central Government.] 

1.  Subs. by G.S.R. 71(E), dt. 30-1-1987. 
2.  Ins. by F.1-19/59-D, dt. 13-6-1967. 
3. Ins. by G.S.R. 245(E), dt. 3-2-1976. 
4. Subs. by G.S.R. 26 (E), dt. 19-1-2006. 

103 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

Provided  that  any  person  who  was  approved  by  the  licensing  authority  as  an 
expert responsible for the manufacture of drugs for the purpose of rule 76 read with 
Rule 78 as these Rules were in force immediately before the 29th June, 1957, shall be 
deemed to be qualified for the purposes of this rule: 

1[Provided  that  for  the  drugs  specified  in  Schedules  C  and  C(1)  meant  for 
veterinary use, the whole time employee under whose supervision  the manufacture is 
conducted may be a graduate in Veterinary Science or general science or medicine or 
pharmacy of a University, recognized by the Central Government and who has had at 
least three years‘ experience in the manufacture of biological products: 

5[Provided  also  that  for  medical  devices,  the  whole  time  employee  under  whose 

supervision the manufacture or testing is conducted shall be—  

(i)  a  graduate  in  Pharmacy  or  Engineering  (in  appropriate  branch)  from  a 
University recognised by the Central Government for such purposes and has 
had  at  least  eighteen  months  practical  experience  in  the  manufacturing  or 
testing of devices to which this licence applies after his graduation; or  
(ii)  a  graduate  in  science,  from  a  University  recognised  by  the  Central 
Government for such purposes, with Physics or Chemistry or Microbiology 
as one of the subject and has had at least three years practical experience in 
the manufacturing or testing of devices to which this licence applies after his 
graduation; or  

(iii)  a diploma in Pharmacy or Engineering (in appropriate branch) from a Board 
or Institute recognised by the Central Government or the State Government, 
as the case may be, for such purposes and has had at least four years practical 
experience  in  the  manufacturing  or  testing  of  devices  to  which  this  licence 
applies after his diploma; or  

(iv)  having  a  foreign  qualification,  the  quality  and  content  of  training  of  which 
are comparable with those specified in clause (i), clause (ii) and clause (iii) 
and is permitted to work as competent technical staff under this rule by the 
Central Government.] 

6[(2) The applicant proposing to manufacture pharmaceutical products shall comply 
with the provisions referred to in Schedule M. 

(2A)  The  applicant  proposing  to  manufacture  medical  devices  and  in-vitro 
diagnostics  shall  comply  with  the  quality  management  system  as  referred  to  in 
Schedule M-III. 

(3)  The  applicant  shall  provide  adequate  space,  plant  and  equipment  for 
pharmaceutical products as referred to in Schedule M and for Medical devices and in-
vitro diagnostics as referred to in Schedule M-III.] 

3[(4)  The  applicant  shall  provide  and  maintain  adequate  staff,  premises  and 
laboratory equipment for carrying out such tests of the strength, quality and purity of 
the  substances as  may  be  required to  be  carried  out  by  him  under  the  provisions of 
Part  X  of  these rules  including proper housing for  animals used  for  the  purposes of 
such tests, the testing unit being separate from the manufacturing unit and the head of 
the testing unit being independent of the head of the manufacturing unit: 

Provided  that  the  manufacturing  units  which  before  the  commencement  of  the 
Drugs  and  Cosmetics  (Amendment)  Rules,  19774,  were  making  arrangements  with 
institutions  approved  by  the  Licensing  Authority  for  such  tests  to  be  carried  out  on 
their behalf may continue such arrangements upto the 30th June, 1977 : 

Provided further that  for tests  requiring sophisticated instrumentation techniques 
or  biological or  microbiological methods other than sterility the  Licensing Authority 
may  permit  such  tests  to  be  conducted  by  institutions  approved  by  it  2[under  Part 
XV (A) of these rules] for this purpose. 
1.  Ins. by F.1-6/62-D (SO 2889), dt. 2-7-1969. 
2.  Ins. by G.S.R 1172 (E), dt. 23-8-1977. 
3. Sub. by G.S.R 926 (E), dt. 24-6-1977. 
4. These rules came in to force on 28th May, 1977 vide G.S.R 665 (E), dt. 6-5-1977. 
5. Sub. by G.S.R 690 (E), dt. 25-9-2014. Earlier Ins. by G.S.R 109 (E), dt. 22-2-1994. 
6. Sub. by G.S.R 640 (E), dt. 29-6-2016.

104 

 
 
 
 Drugs and Cosmetics Rules 1945 

1[(4A)  The  head  of  the  testing  unit  referred  to  in  condition  (4)  shall  possess  a 
degree  in  Medicine  or  Science  or  Pharmacy  or  Pharmaceutical  Chemistry  of  a 
University  recognized  for  this  purpose  and  shall  have  experience  in  the  testing  of 
drugs, which in the opinion of the Licensing authority is considered adequate.] 

(5)  The  applicant  shall  make  adequate  arrangements  for  the  storage  of  drugs 

manufactured by him. 

2[(6)   The applicant shall furnish to the Licensing Authority, if required to do so, 
data  on  the  stability  of  drugs  which  are  likely  to  deteriorate  for  fixing  the  date  of 
expiry which shall be printed on the labels of such drugs on the basis of the data so 
furnished.] 

3[(7)  The  applicant  shall,  while  applying  for  licence  to  manufacture  patent  or 
proprietary medicines, furnish to the Licensing Authority evidence and data justifying 
that the patent or proprietary medicines− 

(i) contain the constituent ingredients in therapeutic/prophylactic quantities 
as determined in relation to the claims or conditions for which the medicines are 

recommended for use or claimed to be useful; 

(ii)    are  safe  for  use  in  the  context  of  the  vehicles,  excipients,  additives  and 
pharmaceutical  aids  used  in  the  formulations  and  under  the  conditions  in  which  the 
formulations for administration and use are recommended; 

(iii) are stable under the conditions of storage recommended; 

(iv)  contain  such  ingredients  and    in    such  quantities  for    which  there    is 

therapeutic   justification.;] and 

4[(v) have the approval, in writing, in favour of the applicant to manufacture drug 
formulations falling under the purview of new drug as defined in Rule 122E, from the 
licensing authority as defined in clause (b) of rule 21.] 

5[(8)  The licensee of pharmaceutical products shall comply with the requirements 
of  ‗Good  Manufacturing  Practices‘  as  laid  down  in  Schedule  M  and  the  licensee  of 
Medical  Devices  and  in-vitro  diagnostics  shall  comply  with  the  requirements  of 
―Quality Management System‖ as laid down in Schedule M-III..] 

1.  Ins. by G.S.R 681 (E), dt. 5-12-1980. 
2.  Ins. by G.S.R 444 dt. 31-3-1973. 
3.  Ins. by G.S.R 515 dt. 24-3-1976. 
4.  Ins. by G.S.R 311 (E), dt. 1-5-2002. 
5.  Subs. by G.S.R 640 (E), dt. 29-06-2016. Previously Ins. by G.S.R 735 (E), dt. 24-6-1988.

105 

 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[Explanation:-  For  the  purpose  of  this  rule,  6[―Large  Volume  Parenterals‖  sera  and 
vaccines  and  recombinant  DNA  (r-DNA)  derived  drugs,]  shall  mean  the  sterile  solutions 
intended for parenteral administration with a volume of 100 ml. or  more (and shall include 
anti-coagulant  solutions) in  one container of the finished dosage form intended for single 
use.] 
      7[(9)  The  applicant  shall  make  application  for  grant  of  licence  for  a  drug  formulation 
containing single active ingredient only in proper name.] 

2[76A.    Forms    of  loan  licenses  to  manufacture  for  sale  or  for  distribution  drugs 
specified in Schedule C and C(1) excluding drugs specified in Schedule X or of Large 
Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs, 
and conditions for the grant or renewal of such license.— A loan license to manufacture 
for sale or for distribution of drugs specified in Schedules C and C(1), excluding  drugs specified 
in  Schedule  X,  and  Large  Volume    Parenterals,  Sera  and  Vaccine  and  Recombinant    DNA(r- 
DNA)  derived  drugs  specified  in  Part  XB  shall  be  issued  in  Form  28A  and  a  loan  license  to 
manufacture  for  sale  or  for  distribution  of  Large  Volume    Parenterals,  Sera  and  Vaccine  and 
Recombinant  DNA (r-DNA) derived drugs shall be issued in Form 28DA, and the applicant shall, 
while  applying  for  a  licence  to  manufacture  patent  or  proprietary  medicines,  furnish  to  the 
Licensing Authority evidence and data justifying that the patent or proprietary medicines-  

(i) contain  the constituent  ingredients  in  therapeutic/prophylactic quantities  as 
determined  in  relation  to  the  claims  or  conditions  for  which    the  medicines  are 
recommended for use or claimed to be useful; 

(ii) are safe for use in the context of the vehicles, excipients, additives and 
pharmaceutical  aids  used  in  the  formulations,  and  under  the  conditions  in 
which the formulations for administration and use are recommended; 

(iii) are stable under the conditions of storage recommended; and 

(iv)  contain  such  ingredients  and  in  such  quantities  for  which  there  is 

therapeutic justification.] 

7[Provided that the application for grant of a licence for a drug formulation 

containing single active ingredient shall be made only in proper name.] 

3[77.  Duration  of  licence. 
Form  28D  or  renewed  licence  in  Forms  26,  26F,  and  Form  26H],  unless  sooner 
suspended or cancelled shall be 5[valid  for a period of five years on and from the date 
on which] it is granted or renewed: 

An  original  licence  in  4[Form  28,  Form  28B  and

1.  Ins. by G.S.R. 119 (E), dt. 11-3-1996. 
2.  Subs. by G.S.R. 574 (E), dt. 17-7-2012.Earlier Subs. by G.S.R. 788 (E), dt. 10-10-1985 and Subs. by G.S.R. 

462 (E), dt. 22-6-1982. 

3.  Amended by No. G.1-10/62-D, dt. 10-4-1964. 
4.  Subs. by G.S.R. 119 (E), dt. 11-3-1996. 
5.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
6. Subs. by G.S.R. 26 (E), dt. 19-1-2006. 
7. Ins. by G.S.R. 570 (E) dt. 7-8-2014. 

106 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[Provided that if the application for the renewal of a  licence is  made before its 
expiry, or if the application is made  within  six months of its  expiry  after  payment 
of   additional fee, the licence shall continue to be in force until orders are passed on 
the application and the licence shall be deemed to have expired if the application for 
its renewal is not made within six months of its expiry.]] 

2[78.  Conditions  of  licence.−A  licence  in  3[Form  28,  Form  28B  or  Form  28D] 
shall  be  subject  to  the  special  conditions,  if  any,  set  out  in  Schedule  F  or 
ScheduleF(1), as the case may  be, which relate  to the substance in  respect of which 
the licence

is granted and to the following general conditions:−

(a)  (i)  The  licensee  shall  provide  and  maintain  an  adequate  staff  and 
adequate  premises  and  plant  for  the  proper  manufacture  and  storage  of  the 
substances in respect of which the licence is issued; 

(ii) Without prejudice to the generality of the foregoing requirement, every 
holder of a licence who for any purpose engaged in the culture or manipulation 
of  pathogenic  spore-bearing  micro-organisms shall  provide  to  the  satisfaction 
of  the  Licensing  Authority  separate  laboratories  and  utensils  and  apparatus 
required  for  the  culture  or  manipulation  of  such  micro-organisms,  the 
laboratories,  utensils  and  apparatus  so  provided  not  being  used  for  the 
manufacture of any other substance; 

4[(b) The licensee shall provide and maintain staff, premises and equipment 

as specified in Rule 76;] 

5[(c)(i)  The  licensee  shall  maintain  records  of   manufacture  as  per 

particulars given in Schedule U; 

(ii)  The  licensee  shall  either  in  his  own  laboratory  or  in  any  laboratory 
approved  by  the  Licensing  Authority  6 [ under  Part  XV  (A)  of  these  rules] 
test each  batch or  lot  of  the  raw  material  used by  him  for  the  manufacture of 
his product and also each batch of the final product and shall maintain records 
or registers  showing  the  particulars  in  respect  of  such  tests  as  specified  
in Schedule  U.    The  records  or  registers  shall  be  retained  in  the  case  of  
a substance for  which  a  potency  date  is  fixed  for  a  period  of  two  years  from 
the expiry  of  such  date,  and  in  the  case  of  other  substances  for  a  period  of 
five years from the date of manufacture;] 

(d)  The  licensee  shall  allow  an  7[Inspector  appointed  under  the  Act]  to 
enter,  with  or  without  prior  notice,  any  premises  where  the  manufacture  is 
carried on  and  to inspect the premises, and in the case of substances specified 
in Schedules C  and C(1), to  inspect the  plant  and  the  process of  manufacture 
and the means employed for standardizing and testing the substance;] 

1.  Amended by S.O. 2139 dt. 12-8-1972. 
2.  Amended by F.1-6/62-B, dt. 2-6-1969. 
3.  Subs. by G.S.R. 119 (E), dt. 11-3-1996. 
4.  Amended by F.1-16/57-D (SO 2136), dt. 15-6-1957. 
5.  Amended by F.1-20/64-D (SO 3868), dt. 26-10-1968. 
6. Ins. by G.S.R. 1172 (E), dt. 23-8-1977. 
7. Subs. by G.S.R. 444 (E), dt. 31-3-1973.

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(e)  The  licensee  shall  allow  an  1[Inspector  appointed  under  the  Act]  to 
inspect  all  registers  and  records  maintained  under  these  Rules  and  to  take 
samples  of the  manufactured product  and  shall  supply  to  such  Inspector  such 
information  as  he  may  require  for  the  purpose  of  ascertaining  whether  the 
provisions of the Act and Rules thereunder have been observed;] 

(f)  The  licensee  shall  from  time  to  time  report  to  the  Licensing  Authority 
any changes in the expert staff responsible for the manufacture or testing of the 
substance  and  any  material  alterations  in  the  premises  or  plant  used  for  that 
purpose  which  have  been  made  since  the  date  of  the  last  inspection  made  on 
behalf of the Licensing Authority before the issue of the licence; 

1[(g)  The  licensee  shall  on  request  furnish  to  the  Licensing  Authority, 
Controlling Authority or  to  such  authorities as  the  Licensing Authority or  the 
Controlling  Authority  may  direct,  from  every  batch  of  drug  as  the  Licensing 
Authority or the Controlling Authority may from time to time specify, a sample 
of  such  quantity  as  may  be  considered  adequate  by  such   Authority  for  any 
examination and, if  so  required, also  furnish, full  protocols of  the  tests  which 
have been applied;] 

2[(h) If the Licensing Authority or the Controlling Authority so  directs, the 
licensee shall not sell or offer for sale any batch in respect of which a sample 
is,  or  protocols  are  furnished  under  the  last  preceding  sub-paragraph  until  a 
certificate  authorising  the  sale  of  the  batch  has  been  issued  to  him  by  or  on 
behalf of the Licensing Authority or the Controlling Authority;] 

1[(i) The licensee shall on being informed by the Licensing Authority or the 
Controlling  Authority  that  any  part  of  any  batch  of  the  substance  has  been 
found by the Licensing Authority or the Controlling Authority not to conform 
with the standards of strength, quality or purity specified in these rules and on 
being directed so to do, withdraw the remainder of that batch from sale and so 
far as  may  in  the particular circumstances of the case be practicable recall  all 
issues already made from that batch;] 

(j)  No  drug  manufactured  under  the  licence  shall  be  sold  unless  the 
precautions  necessary  for  preserving  its  properties  have  been  observed 
throughout the period after manufacture; 

3[(k) The licensee shall comply with the provisions of the Act and of these 
rules  and  with  such  further  requirements,  if  any,  as  may  be  specified  in  any 
rules  subsequently  made  under  Chapter  IV  of  the  Act,  provided  that  where 
such  further  requirements  are  specified  in  the  rules,  these  would  come  into 
force four months after publication in the Official Gazette;] 

1.  Subs. by G.S.R 444, dt. 28-4-1973. 
2. Amended by F.1-16/57-D, dt. 15-6-1957. 
3. Amended by F.1-14/68-B (SO 3868), dt. 26-10-1968.

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1[(l)  The  licensee  shall  maintain  an  Inspection  Book  in  Form  35  to  enable  an 

Inspector to record his impression and defects noticed.] 

2[(m) The licensee shall maintain reference samples from each batch of the drugs 
manufactured  by  him  in  a  quantity  which  is  at  least  twice  the  quantity  of  the  drug 
required to conduct all the tests performed on the batch.   In case of drugs bearing an 
expiry  date  on  the  label,  the  reference  samples  shall  be  maintained  for  a  period  of 
three months beyond the date of expiry of potency.  In case of drugs where no date of 
expiry is specified on the label the reference samples shall be maintained for a period 
of three years from the date of manufacture.] 

3[(n) The licensee, who has been granted a license in Form 28B shall−

(i)   forward     to   the   licensing  authority  of   the   concerned  States     of 
manufacture  and    supply  of  the  drug  a  statement  of  the  sales  effected  to 
manufacturers,  wholesalers,    retailers,    hospitals,    dispensaries    and    Nursing 
Homes and Registered Medical Practitioners every three months; 

(ii)  maintain accounts of  all  transactions giving details as  indicated below 
in  a  register  bound  and  serially  page  numbered  and  such  records  shall  be 
retained  for  a  period  of  five  years  or  one  year  after  the  expiry  of  potency, 
whichever is later. 

A.     Accounts of the drugs specified in Schedule X used for the manufacture:- 

1.    Date of issue. 

2.    Name of the drug. 

3.    Opening balance of stock on the production day. 

4.    Quantity received, if any, and source from where received. 

5.    Quantity used in manufacture. 

6.    Balance quantity on hand at the end of the production day. 

7.    Signature of the person in charge. 

1.  Subs. by F.1-14/68-B (SO3868), dt. 26-10-1968. 
2.  Ins. by G.S.R. 444, dt. 28-4-1973. 
3.  Ins. by G.S.R. 462 (E), dt. 22-6-1982.

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B.   Accounts of Production: 

1.    Date of manufacture. 

2.    Name of the drug. 

3.    Batch Number. 

4.    Quantity of raw material used in manufacture. 

5.    Anticipated yield. 

6.    Actual yield. 

7     Wastage. 

8.    Quantity of the manufactured goods transferred.  

C.   Accounts of the manufactured drugs: 

1.    Date of manufacture. 

2.    Name of the drug. 

3.    Batch Number. 

4.    Opening Balance. 

5.    Quantity manufactured. 

6.    Quantity sold. 

7.    Name of the purchaser and his address. 

8.    Balance quantity at the end of the day. 

(o)  The  licensee  shall  store  drugs  specified  in  Schedule  X  in  bulk  form 
and when any of such drug is required for manufacture in a place other than its 
place of storage it shall be kept in a separate place under the direct custody of a 
responsible person.] 

1[(p)   The   licensee   shall   comply   with   the   requirements   of  3[‗Good 
Manufacturing Practices‘ as laid down in Schedule L-1 and Good Manufacturing 
Practices‘ as laid down in Schedule M.] 

4[(q) No advertisement of the drugs specified in Schedule H, Schedule H1 or 
Schedule  X  shall  be  made  except  with  the  previous  sanction  of  the  Central 
Government.] 

2[78A.  Conditions  of  license  in  5[Form  28A  or  Form  28DA]-  (1)  The  license  in 
5[Form  28A  of  Form  28DA]  shall  be  deemed  to  be  cancelled  or  suspended,  if  the 
licence  owned  by  the  licensee  in  6[5[Form  28  or  Form  28D]  whose  manufacturing 
facilities  have  been  availed of  by  the  licensee is cancelled or suspended, as the case 
may be, under these rules. 

1.  Ins. by G.S.R. 735 (E), dt. 24-6-1998. 
2.  Amended by F.1-14/68-D (S.O. 3868), dt. 26-10-1968. 
3. Ins. by G.S.R. 780 (E), dt. 10-9-2008. 
4. Ins. by G.S.R. 289 (E), dt. 15-4-2015. 
5. Subs. by G.S.R. 574 (E), dt. 17-7-2012. 
6. Subs. by G.S.R. 592 (E), dt. 13-8-2008. 

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(2) The  licensee  shall  comply with  the  provisions of  the  Act,  and  of  these  rules 
and  with  such  further  requirements  if  any,  as  may  be  specified  in  any  rules 
subsequently  made  under  Chapter  IV  of  the  Act,  provided  that  where  such  further 
requirements are specified in the rules, those would come into force four months after 
publication in the Official Gazette. 

(3)     The licensee shall test each batch or lot of the raw material used by him for 
the  manufacture  of  his  products  and  also  each  batch  of  the  final  product  and  shall 
maintain  records  or  registers  showing  the  particulars  in  respect  of  such  tests  as 
specified  in  Schedule  U.      Records  or  registers  shall  be  retained,  in  the  case  of  a 
substance for which a potency date is fixed, for a period of two years from the expiry 
of  such date and in the case of  other substances, for a  period of  five years from the 
date of manufacture.  The licensee shall allow an Inspector to inspect all registers and 
records  maintained  under  these  rules  and   shall   supply  to   the   Inspector  such 
information as he may require for the purpose of ascertaining whether the provisions 
of the Act and these rules have been observed. 

(4)     The licensee shall either (i) provide and maintain to the satisfaction of the 
Licensing Authority adequate staff and adequate laboratory facilities for carrying out 
tests of the strength, quality and purity of the substances manufactured by him, or (ii) 
make  arrangements  with  some  institution  approved  by  the  Licensing  Authority  for 
such tests to be regularly carried out on his behalf by the institution.] 

1[(5)   The licensee shall furnish to the Licensing Authority, if required to do so, 
data  on  the  stability  of  drugs  which  are  likely  to  deteriorate  for  fixing  the  date  of 
expiry which would be printed on the labels of such drugs on the basis of the data so 
furnished.] 

2[(6)  The  licensee  shall  maintain reference samples  from  each  batch  of  the  drug 
manufactured  by  him  in  a  quantity  which  is  at  least  twice  the  quantity  of  the  drug 
required to conduct all the tests performed on the batch.   In case of drugs bearing an 
expiry  date  on  the  labels,  the  reference samples  shall  be  maintained for  a  period  of 
three months beyond the date of expiry of potency.  In case of drugs where no date of 
expiry of potency is specified on the label, the reference samples shall be maintained 
for a period of three years from the date of manufacture.] 

3[(7)  The  licensee  shall  maintain  an  Inspection  Book  in  Form  35  to  enable  an 

Inspector to record his impressions and the defects noticed.] 

4[(8)  No  advertisement  of  the  drugs  specified  in  Schedule  H,  Schedule  H1  or 
Schedule  X  shall  be  made  except  with  the  previous  sanction  of  the  Central 
Government. 

5[79. Inspection  before  grant or  renewal  of  licence.−Before a licence  under 

1. 
Ins. by G.S.R. 444, dt. 28-4-1973. 
2.  Subs. by G.S.R. 574 (E), dt. 17-7-2012. 
3. 
Ins. by G.S.R. 331 (E), dt. 8-5-1984. 
4. 
Ins. by G.S.R. 289 (E), dt. 15-4-2015. 
5.  Subs. by G.S.R. 923 (E), dt. 14-12-1992.

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this Part is granted or renewed the Licensing Authority or Central Licence Approving 
Authority,  as   the   case   may   be,     shall   cause   the   establishment  in   which   the 
manufacture is  proposed to  be conducted or being conducted to be inspected by  one 
or  more  Inspectors  appointed  under  this  Act  with  or  without  an  expert  in  the 
concerned  field.  The  Inspector  or  Inspectors  shall  examine  all  portions  of  the 
premises, plant and appliances and also inspect   the process of manufacture intended 
to  be  employed or  being  employed along  with   the  means  to  be  employed or  being 
employed  for  standardizing  and  testing  the  drugs  to  be  manufactured  or  being 
manufactured and enquire into the professional qualifications of the technical staff to 
be employed. He shall also examine and verify the statements made in the application 
in  regard to  their  correctness, and  the capability of  the  applicant to  comply with  the 
requirements  of  competent  technical  staff,  manufacturing  plants,  testing  equipments 
and  the  ‗Requirements of  Good  Manufacturing Practices‘  and  the  ‗Requirements of 
Plant  and  Equipment‘  as  laid  down  in  Schedule  M  read  with  the  Requirements  of 
Maintenance of Records as laid down in Schedule U.] 

1[80.  Report  by  Inspector.−The  Inspector     shall  forward  a  detailed  descriptive 
report    giving    his    findings   on    each    aspect   of    inspection   along    with   his 
recommendations after completion of his inspection in accordance with the provisions 
of  Rule  79,  to  the  Licensing  Authority  or  Central  Licence  Approving  Authority,  as 
the case may be.] 

81.  Procedure  of  Licensing  Authority.−(1) If  the  Licensing  Authority  5[or 
Central Licence Approving Authority, as the case may be,] after such further enquiry, 
if  any,  as  he  may  consider necessary, is  satisfied that  the  requirements of  the  Rules 
under the Act have been complied with and that the conditions of the licence and the 
Rules under the Act will be observed, he 2[shall issue a licence  under this Part]. 

(2)     If the Licensing Authority 5[or Central Licence Approving Authority, as the 
case  may  be,] is  not  so  satisfied, he  shall reject  the  application and  shall inform the 
applicant  of  the  reasons  for  such  rejection  and  of  the  conditions  which  must  be 
satisfied before a licence can be granted and shall supply the applicant with a copy of 
the inspection report. 

3[82. Further application after rejection. −If  within a period of six months from 
the  rejection  of  an  application  for  a  licence  the  applicant  informs  the  Licensing 
Authority  5[or  Central  Licence  Approving  Authority,  as  the  case  may  be,]  that  the 
conditions  laid  down  have  been  satisfied  and  deposits  an  inspection  4[fee  of  rupees 
two  hundred  and  fifty]  the  Licensing  Authority  5[or  Central  Licence  Approving 
Authority, as the case may be,] may, if after causing a further inspection to be made, 
he is satisfied that the conditions for the grant of a licence have been complied with, 
5[in respect of drugs notified under Rule 68-A] issue a licence in Form 28 2[or Form 
28-B]. 

1. Subs. by G.S.R. 923 (E), dt. 14-12-1992. 
2.  Ins. by G.S.R. 462 (E), dt. 22-6-1982. 
3.  Ins. by F.1-16/57-D, dt. 15-6-1957. 
4.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
5. Ins. by G.S.R. 923 (E), dt. 14-12-1992.

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83.    Renewal.−On  application  being  made  for  renewal,  the  licensing  authority 
may cause an inspection to be made and, if satisfied that the condition of the licence 
and the Rules under the Act are, and will continue to be observed, 1[he shall prepare a 
report to that effect in respect of those drugs which have been notified by the Central 
Government under Rule 68-A and forward it along with the application to the Central 
Licence  Approving  Authority],  and  shall  issue  a  certificate  of  renewal  3[under  this 
Part]. 

3[83-A.    Certificate of renewal of a loan licence.−The certificate of renewal of a 
loan licence in 8[Form 28A or Form 28DA] shall be issued in Form 26A or Form 26J 
respectively.] 

4[83-AA.   Duration of loan licence.−An original loan licence in  8[Form 28A or 
Form  28DA]  or  a  renewed  loan  licence  in  8[ Form  26A  or  Form  J],  unless  sooner 
suspended  or  cancelled,  shall  be  5[valid  for  a  period  of  five  years  on  and  from  the 
date on which] it is granted or renewed: 

6[Provided that if the application for the renewal of a  licence is  made before its 
expiry, or if the application is made within six months of its expiry, after payment of 
the additional fee, the licence shall continue to be in force until orders are passed on 
the application and the licence shall be deemed to have expired if the application for 
its renewal is not made within six months of its expiry].] 

84.   The provisions of this Part shall apply to the manufacture of drugs for sale 

notwithstanding that such drugs are manufactured for sale outside India. 

7[6[84-A.    Provision for appeal to the State Government or Central Government 

by  party  whose  licence  has  not  been  granted  or  renewed.−   
Any person who is aggrieved by the order passed by the Licensing Authority   or the 
Central Licence Approving Authority, as the case may be, refusing to 2[grant or renew 
a licence under this Part], may  within thirty  days  from  the  date of  receipt of such 
order,  appeal  to  the  State  Government  or  Central  Government,  as  the  case  may 
be,  and  the  State Government  or  the  Central  Government may,  after such  enquiry 
into  the  matter,] as  is  considered  necessary  and  after  giving  the  said  person  an  
opportunity    for  representing his views, may pass such order in relation thereto as it 
thinks fit.] 

1.  Ins. by G.S.R. 923 (E), dt. 14-12-1992. 
2.  Subs. by G.S.R. 119 (E), dt. 11-3-1996.. 
3.  Ins. by F1-16/57-B, dt. 15-6-1957. 
4.  Ins. by Notfn. No. F. 1-10/62-D, dt. 10-4-1964. 
5.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
6.  Subs. by S.O. 2139, dt. 12-8-1972. 
7.  Subs. by G.S.R. 923 (E), dt. 14-12-1992 as corrected by G.S.R. 373 (E), dt. 13-4-1993. 
8. Subs. by G.S.R. 574 (E), dt. 17-5-2012. 

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